Drugs Update

New drugs approved for marketing in India during November-December 2011

Source: http://cdsco.nic.in

Diazinon Flea Drops Spot on Dogs 30.0% w/w	For dogs infected with fleas.
Cabazitaxel Injection 60mg / 1.5ml	In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.
Trifluridine Eye Drops 1% w/v	For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.
Fosaprepitant (as Dimeglumine) for Injection 150mg.	1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.
Abiraterone Acetate Tablets 250mg	In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.
Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg	For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.
Crizotinib  hard gelatin Capsules 200mg/250mg	For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test.

Drugs  banned in India in 2011

Source: http://cdsco.nic.in

1.      Gatifloxacin

2.      Tegaserod

3.      Nimesulide for children below 12 years.

4.      Cisapride

5.      Phenyl propanolamine

6.      Human placental extract

7.      Sibutramine

8.      R-Sibutramine

FDA approvals in January 2012

Source: http://drugs.com

1.      Fentanyl Sublingual Spray

Opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.

2.      Glucarpidase Injection

Carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.

3.      Ciclesonide Nasal Aerosol

Corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.

4.      Ingenol mebutate Topical Gel

Inducer of cell death indicated for the topical treatment of actinic keratosis.

5.      Axitinib Tablets        

Kinase inhibitor indicated for the treatment of advanced renal cell carcinoma

6.      Exenatide Extended-Release Injectable Suspension

Glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

7.      Vismodegib Capsules

Hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).

8.      Ivacaftor Tablets

Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.

Promising Therapies in Diabetes Mellitus

Diabetes mellitus (DM) results from defects in insulin secretion (type 1) or insulin resistance (type 2). Insulin is used to manage type 1 DM, and oral hypoglycemic agents are used to manage type 2 DM. These therapies are inconsistent in maintaining glycemic control and cause some severe adverse effects such as undue weight gain and hypoglycemia. New and appropriate therapies are needed to overcome these problems. Drugs that are in the pipeline include oral insulins for type 1 DM and incretin mimetics, incretin enhancers, gastric inhibitory peptides, amylin analogues, peroxisome proliferator-activated receptor-α/γ ligands, sodium-dependent glucose transporter inhibitors, and fructose 1,6-bisphosphatase inhibitors for type 2 DM.

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Top Ten Health Stories of the Year 2010

The year 2010 saw a lot of ‘hustle and bustle’ in the medical circle. Here are the Top 10 stories as viewed by eMedinewS.

1. Overhauling of Medical Council of India: The major story of the year was the arrest of MCI President Dr. Ketan Desai, dissolution of the MCI; appointment of six out of seven Board of Governors; subsequent release of Dr. Ketan Desai on bail, common entrance exam for MBBS; reduction in forensic faculty requirement; increase in retirement age to seventy and the suspense behind 7th seat of Board of Governors etc.
2. Medical Council of India action against Indian Medical Association: MCI took action against the IMA President and Secretary for violation of MCI Ethics on the ground that IMA should not have endorsed Pepsi products. The IMA had to approach High Court to take a stay. The matter is now in the High Court. Is that a start of MCI actions against ethics violations? Will it act against the cut system?
3. Delhi Bug: A huge controversy arose when British Medical Journal broke a story about NDM1 bug being named after New Delhi. The medical circle in India said that it was unfair and was an attempt to sabotage the medical tourism in India. The new bug is a gram negative bacteria showing resistance to all present antibiotics. New Delhi metallo–beta–lactamase (NDM–1) is an enzyme that makes bacteria resistant to a broad range of beta–lactam antibiotics. These include the antibiotics of the carbapenem family, which are a mainstay for the treatment of antibiotic–resistant bacterial infections. The gene for NDM–1 is one member of a large gene family that encodes beta–lactamase enzymes called carbapenemases. Bacteria that produce carbapenemases are often referred to in the news media as “superbugs” because infections caused by them are difficult to treat. Such bacteria are usually only susceptible to polymyxins and tigecycline. NDM–1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008. It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States, Canada, Japan and Brazil. The most common bacteria that make this enzyme are Gram negative such as Escherichia coli and K. pneumoniae, but the gene for NDM–1 can spread from one strain of bacteria to another by horizontal gene transfer.
4. H1N1 havoc: H1N1 created great havoc, but ultimately, proved to be a ‘much hyped’ virus with mortality even lower than the regular human flu virus. Most of the hospitals who had started special H1N1 virus wards, now do not have these wards.
5. Chikungunya epidemic: The latest epidemic in the North India was that of Chikungunya with patients presenting with fever, rash and joint pains. It complicated the pre–existing dengue epidemic in the society.
6. Dengue with a difference: This year dengue was different than other years, came with more GI symptoms, pancreas involvement, dengue hepatopathy and lot of skin reactions. The platelet count dropped to less than 10000 but most required no platelet transfusion.
7. Diabetes diagnosis: The year saw a new advancement where A1C is to be used for diagnosis of diabetes and not fasting sugar. An A1C >6.5% means diabetes.
8. New pill for HIV prevention: A new pill is now available for HIV prevention along with condoms. It is to be used before the act and continues for seven days. In a trial involving nearly 2,500 HIV–negative, but high risk, gay men in six countries, researchers found that a combination antiretroviral pill (tenofovir and emtricitabine) reduced the risk of HIV infection by 44%, compared with placebo. When scientists looked more carefully at the study volunteers who took the medication most faithfully, on a daily basis, they found that the risk of contracting HIV was even lower — 73% lower than the placebo group. More studies will need to confirm the benefit of antiretrovirals in the prevention of HIV, and public health experts warn that even if the results hold up, it would not replace the best method of prophylaxis: safe sex and consistent use of condoms. That’s because the way so–called pre–exposure prophylaxis, or PrEP, works is to load up high–risk people with HIV–disabling antiretroviral drugs before exposure to the virus, which allows the medication to hit HIV as early as possible. But the drugs do not work as a vaccine would, by priming the immune system to actually prevent infection.
9. National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) started in the country:At last, Govt. of India, Ministry of Health and Family Welfare has started the above program.
10. New drug for premature ejaculation: The year ended with the launch of an SOS drug for premature ejaculation. This will be breakthrough for the community. Premature ejaculation, the most common sexual problem apart from erectile dysfunction, has been often found to put marriages under strain. While the existing drugs, which are not specific to treat premature ejaculation, need to be taken regularly, the new pill can be popped just a few hours before intercourse. It works by altering levels of serotonin, a chemical in the brain. The drug, dapoxetine, comes from a family of drugs called selective serotonin reuptake inhibitors, which block the reabsorption of the neurotransmitter serotonin.

New molecular entities (NMEs) approved in 2010

• Asenapine (Saphris, Merck & Co., Inc.)
• Bepotastine (Bepreve, ISTA Pharmaceuticals)
• Dronedarone (Multaq, Sanofi-aventis)
• Liraglutide (Victoza, Novo Nordisk)
• Tocilizumab (Actemra, Genentech)
• Ustekinumab (Stelara, Centocor Ortho Biotech)
• For details see http://www.medscape.com/viewarticle/731720

• New Drug Review 2010

  Jack DeRuiter, PhD; Pamela L. Holston, RPh, BS, BA
  Posted: 11/10/2010; US Pharmacist © 2010 Jobson Publishing

Onabotulinumtoxin A for Migraine

The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox; Allergan Inc) for headache prophylaxis in patients with adult chronic migraine who suffer headaches on 15 or more days per month, each lasting more than 4 hours.

    To treat chronic migraine, onabotulinumtoxinA is given approximately every 12 weeks as multiple injections around the head and neck. The recommended dose is 155 units (1 mL) divided across 7 head and neck muscles, administered at intervals of at least 12 weeks.

The most common adverse reactions reported by patients being treated with onabotulinumtoxinA for chronic migraine were neck pain (9%) and headache (5%).

Marketed as Botox and Botox Cosmetic, onabotulinumtoxinA has a boxed warning that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.Symptoms include swallowing and breathing difficulties that can be life-threatening.

 Source: FDA New Drug Web site (www.fda.gov)

New anticancer nanoparticle drug containing small interfering RNAs

Agents tageting small interfering RNAs (siRNA) for use in cancer have been developed. The phase 1 clinical trials are over and the results were recently published in Nature.

CALAA-01 is a nanoparticle drug containing small interfering RNAs targeted to ribonucleside reductase M2. This is used in solid tumors that are refractory to therapy.

This opens an entirely new class of anticancer agents.

Oral Insulin

1) The FDA has approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program.


The spray delivers prandial insulin orally through a device similar to an asthma inhaler, which sprays it on the inside of the cheek, rather than via injection.

Researchers have spent much time looking for alternative means of dispensing insulin to diabetics, and the IND program allows patients with serious or life-threatening conditions, and without suitable alternative treatment, to access drugs otherwise available only to those in a clinical trial.



2) Oramed has developed a tablet form of insulin in which the hormone's protein structure is supposedly protected by special adjuvants from destruction by gastric juice. The firm just reported positive results from a Phase 2A clinical trial with Type I diabetics.

New screening method for Anticancer drugs

Many researchers believe tumour growth is driven by cancerous stem cells that, for reasons not yet understood, are highly resistant to standard treatments. Chemotherapeutic agents may kill off 99 percent of the cells in a tumor, but the stem cells that remain can make the cancer recur or spread to other tissues in the body to cause new cancers.

Stem cells, unlike mature cells, can constantly renew themselves and are thought to be the source of cancers when, through mutations in their DNA, they throw off their natural restraints.
a team at the Broad Institute devised a way of screening for drugs that attack cancer stem cells but leave ordinary cells unharmed.

Cancer stem cells are hard to maintain in sufficient numbers, but the Broad Institute team devised a genetic manipulation to keep breast cancer stem cells trapped in the stem cell state.

The team, led by Piyush B. Gupta, screened some 16,000 chemicals, including all known chemotherapeutic agents approved by the FDA. The team reported in the Cell that 32 of the chemicals selectively went after cancer stem cells. The screening system proves for the first time that it is possible to single out cancer stem cells with drugs that leave ordinary cells alone. Only one of the 32 chemicals is approved as a drug for cancer.

Another approach to concentrating on cancer stem cells, based on the use of antibodies, was reported this month by OncoMed Pharmaceuticals.

The cancer stem cell theory has been thrust into the spotlight in the last five years with the discovery of stem cells in many types of solid tumors, including those of the breast, brain, prostate, colon, bladder and pancreas.

Source: http://www.nytimes.com/2009/08/14/health/research/14cancer.html?_r=1&8au&emc=au

Newer drugs for Epilepsy

Lacosamide

Lacosamide is an amino acid-related compound that has been studied in both pain syndromes and partial seizures.

Mechanism of Action: Lacosamide enhances slow inactivation of voltage-gated Na+ channels. It also binds to the collapsin-response mediator protein, CRMP-2, thereby blocking the effect of neurotrophic factors such as BDNF and NT3 on axonal and dendritic growth.

Rufinamide

Rufinamide is a new triazole derivative with little similarity to other antiseizure drugs. It is approved for use in Lennox-Gastaut syndrome and preliminary evidence suggests that it may also be useful in other difficult-to-treat epilepsy syndromes.

Single daily poly-pill for HIV

In a prospective, randomized trial, a single daily tablet containing efavirenz, emtricitabine, and tenofovir (Atripla; Bristol Myers Squibb & Gilead Sciences LLC) maintained viral suppression in HIV-1 infected patients as well as the standard multiple-pill regimen.

The report of the study, published in the Journal of the Acquired Immune Deficiency Syndrome, notes that at baseline, all 300 participants were on stable antiretroviral therapy (ART) regimens, with viral loads of less than 200 copies/mL for at least 3 months. Their mean CD4 count was 540 cells/�L, and 96% of subjects had HIV-1 RNA <50>

On randomization, 203 were assigned to the Atripla regimen while 97 remained on their baseline regimen. The entire 48-week study was completed by 266 patients.

In the intent-to-treat analysis, it was found that at 48 weeks, the primary endpoint -- HIV-1 RNA below 200 copies/mL -- had been achieved by 89% of the patients in the single-tablet group versus 88% of those on unmodified antiretroviral regimens, "indicating noninferiority" of the newer approach.

Similarly, there was no significant difference between groups in maintenance of viral load below 50 copies/mL and no significant changes in CD4 cell counts within or between the two arms of the study.

Discontinuation rates were similar between the groups, but more patients in the single-tablet group discontinued due to adverse events, "most commonly for nervous system symptoms," according to the investigators.

Three patients in the single-tablet group and one in the control group had virologic failure.

"In summary," the researchers conclude, "patients who were stable and virologically suppressed while receiving a wide array of non-nucleoside reverse transcriptase inhibitor- and protease inhibitor-based antiretroviral regimens and had their treatment simplified to a single-tablet regimen of efavirenz, emtricitabine, and tenofovir maintained high rates of virologic suppression compared to those who continued their regimen unmodified."

Source: J Acquir Immune Defic Syndr 2009;51:163-174.

Ceftobiprole: first cephalosporin with activity against MRSA

Ceftobiprole is the first member of a new series of advanced cephalosporins with activity against methicillin-resistant Staphylococcus aureus (MRSA). The drug received a letter of approval from the United States Food and Drug Administration (FDA) in March 2008 for the treatment of complicated skin and skin structure infections including diabetic foot infections. Ceftobiprole exerts its antibacterial activity by inhibiting the penicillin-binding proteins (PBPs) involved in cell wall synthesis. It is stable against hydrolysis by many gram-positive beta-lactamases and a has higher affinity for various PBPs (such as PBP2a of MRSA or PBP2x of Streptococcus pneumoniae), which leads to a wider spectrum of activity compared with older beta-lactams. Ceftobiprole activity does not cover extended-spectrum beta-lactamase-producing Enterobacteriaceae and some other pathogens, including Enterococcus faecium or Acinetobacter baumanii.
Generally well tolerated, with nausea and taste disturbance being the most common adverse events, ceftobiprole appeared noninferior to empiric therapy in several clinical trials. Several precautions regarding hypersensitivity and drug incompatibility are reported.
Ceftobiprole is available only for i.v. administration. Dosage recommendations are 500 mg as a 1-hour intravenous infusion every 12 hours for the treatment of complicated skin and skin structure infections caused by certain gram-positive pathogens, and 500 mg as a 2-hour infusion every 8 hours when susceptible gram-negative or both gram-positive and susceptible gram-negative pathogens are involved. Dosage adjustments are indicated for patients with moderate or severe renal impairment, and dosage recommendations are expected to be 500 or 250 mg, respectively, as a 2-hour infusion every 12 hours.
Ceftobiprole represents a promising option for the treatment of mono- and polymicrobial infections caused by multidrug-resistant gram-positive and susceptible gram-negative pathogens, but further toxicity and safety studies are warranted.

Some new drug approvals in June 2009

Simponi
Pharmacological class: TNF blocker.
Active Ingredient: Golimumab 50mg/0.5mL; soln for SC inj; preservative-free.
Indication: Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).
Company: Centocor Ortho Biotech, Inc.

Axert approved for migraine treatment in adolescents

The FDA has approved Axert (almotriptan malate tablets, from Ortho-McNeil Janssen), a selective 5-HT1B/1D receptor agonist, for the acute treatment of migraine headache in adolescents 12-17 years of age with a history of migraine attacks lasting ≥4 hours.

Reclast approved for biennial dosing regimen to prevent female osteoporosis

The FDA has approved Reclast (zoledronic acid, from Novartis) injection for the prevention of osteoporosis in women for two years with a single dose.

Lamictal XR approved for treatment of epilepsy

GlaxoSmithKline announced that the FDA has approved Lamictal XR (lamotrigine extended-release tablets) as a once-a-day add-on therapy for epilepsy patients ≥13 years of age with partial onset seizures.

Nuvigil launched for excessive sleepiness

Nuvigil (armodafinil tablets) is now available from Cephalon in 50mg, 150mg, and 250mg dosage strengths.

Vyvanse approved for pediatric ADHD control 13 hours post-dose

Shire Pharmaceuticals has received FDA approval for a labeling change for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment Vyvanse (lisdexamfetamine dimesylate capsules).

Cycloset -a new antidiabetic

The U.S. FDA approved Cycloset, a new quick-release oral formulation of bromocriptine mesylateis, which is the first therapy directly targeting the body’s dopamine activity to improve glycemic control. It is also the only drug to be approved subsequent to the FDA's guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk.

Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in “resetting” the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial (after-meal) glucose without increasing plasma insulin concentrations, and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.

Mechanism: Bromocriptine mesylate, an ergot derivative, is a sympatholytic dopamine D2 agonist that exerts inhibitory effects on serotonin turnover in the central nervous system. It has been proposed that bromocriptine can reverse many of the metabolic alterations associated with obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activitties. Indeed, bromocriptine, if administered systemically or into the cerebral ventricle during the early hours of the light cycle, prevents or reverses seasonal fattening, insulin resistance, and decreased endogenous (hepatic) glucose production in mammals. Moreover, timed bromocriptine treatment decreased body weight and improved glucose tolerance in obese individuals who were instructed to follow a hypocaloric diet . Bromocriptine has also been shown to reduce mean daylong plasma glucose, triglyceride, and free fatty acid (FFA) levels in the absence of a change in body weight in obese nondiabetic women.

s-metoprolol for hypertension and heart failure

Although theoretically 3rd generation beta blockers such as nebivolol are supposed to be more advantagious over cardioselective ones due to their additional vasodilating property because of action on alpha receptors, Randomized Controlled trials have failed to show their additional benefits. Since s-metoprolol has more benefits compared to r isomer, it can be predicted that it would be advantagious over both cardioselective as well as 3rd generation beta blockers. As per my knowledge, this hypothesis is still to be tested in clinical trials and is a potential area of research.
Reference: http://heart.bmj.com/cgi/content/abstract/79/1/86
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VRS-4W4CMKG-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=df55a75133229d114817e3a9d61ec2c2

New drug target for epilepsy

Scientists have identified a specific molecular target whose increased activity is linked with seizure disorders- a potassium channel known as the BK channel.

A new anticonvulsant compound that eliminates seizures in a model of epilepsy. The drug works by inhibiting ion channels whose role in epilepsy was only recently discovered. Understanding how these channels work in seizure disorders, and being able to target them with a simple treatment, represents a significant advance in our ability to understand and treat epilepsy. Researchers have found that after a first seizure, BK channel function was markedly enhanced.

Thus, the neurons became overly excitable and were firing with more speed, intensity and spontaneity, which led the researchers to believe that the abnormal increase in the activity of the channels might play a role in causing subsequent seizures and the emergence of epilepsy. In a recent study the researchers tested this theory by blocking the ion channels using a BK-channel antagonist called paxilline.
Using an experimental model for epilepsy, Barth tested whether paxilline could reduce or prevent experimentally induced seizures, as it could normalize aberrant brain activity induced by previous seizures.

And to their surprise, the researchers discovered that the compound was effective at completely blocking subsequent seizures. The drug is orally available, and works in the low nanomolar range.
As the drug is effective in low concentrations and can be taken as a pill, it could turn out to be an especially promising compound for treatment in epilepsy patients.

The findings have been published in the current issue of the journal Epilepsia.

Novel agents and approaches for breast cancer

Cytotoxic chemotherapy remains an important part of the treatment paradigm for breast cancer. Anthracyclines and taxanes are the most active agents; however, limitations with their use include a maximum lifetime dose and tumor resistance with anthracycline, hypersensitivity reactions and cumulative toxicity with taxanes.

• Therefore, to meet these challenges, the development of new cytotoxics and novel taxane formulations is an important area of active research. Several recent advances have been made. Epothilones represent a novel group of cytotoxic agents, with proven activity in breast cancer.
• Nanoparticle drug delivery systems have led to the development of ABI-007, which has demonstrated superior response rates than 3-weekly paclitaxel, with a lower risk of hypersensitivity reactions.
• To circumvent the problem of taxane resistance, larotaxel, a semisynthetic taxoid, and vinflunine, a synthetic vinca alkaloid, have been developed with encouraging clinical results to date.
• Eribulin, a synthetic derivative of halichondrin has recently entered Phase III trials based on encouraging activity in heavily pretreated patients.
• A further novel approach is the conjugation of cytotoxic agents to targeted agents, such as with trastuzumab-MCC-DM1.

New Pharmacological Drug Classes Introduced in 2008

Pharmacologic Class	First to be Marketed in the U.S.	FDA Approved Indication	11th Edition Reference
C1 inhibitor	C1 inhibitor (Cinryze)	Routine prophylaxis against angioedema attacks in patients with hereditary angioedema	page 1405
CXCR4 chemokine receptor inhibitor	plerixa (Mozobil)	Mobilization of granulocyte-colony stimulating factor induced hematopoietic stem cells to the peripheral blood prior to collection	page 1274
peripherally acting µ-opioid receptor antagonist	alvimopan (Entereg)	Acceleration of the time to gastrointestinal recovery following bowel surgery	pages 561-562
	methylnaltrexone (Relistor)	Treatment of opioid-induced constipation
thrombopoietin receptor agonist	eltrombopag (Promacta)	Treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura	pages 1441-1442
	romiplostim (Nplate)

Drugs Licensed in 2008 With Mechanisms Similar to Previously Approved Drugs

Generic Name	Brand Name	Pharmacology	2008 FDA Approved Indication	Pharmacologically Similar Agents	11th Edition Reference
bendamustine	Treanda	alkylating agent	Treatment of chronic lymphocytic leukemia	busulfan, carmustine, chlorambucil, cyclophosphamide, ifosfamide, melphalan	pages 1322-1327
certolizumab	Cimzia	tumor necrosis factor inhibitor	Management of Chron's disease	infliximab	page 1419
clevidipine	Cleviprex	dihydropyridine calcium channel antagonist	Treatment of hypertension	amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine nisoldipine	pages 832-838, 857-858
degarelix	none	GnRH receptor antagonist	Treatment of prostate cancer	goserelin, histrelin, leuprolide, triptorelin	pages 1387-1388
desvenlafaxine (major metabolite of venlafaxine)	Pristiq	selective serotonin and norepinephrine reuptake inhibitor	Treatment of major depressive disorder	venlafaxine	pages 434t, 437t, 439t, 444t,
difluprednate	Durezol	opthalmic corticosteroid	Treatment of ocular inflammation	prednisolone	pages 1724-1725
ethinyl estradiol/levonorgestrel	LoSeasonique	oral contraceptive	Prevention of pregnancy	ethinyl estradiol/levonorgestrel (Seasonique)	pages 1563-1567
etravirine	Intelence	non-nucleoside reverse transcriptase inhibitor	Treatment of HIV-1 infection	delavridine, efavirenz, nevirapine	pages 1292-1297
fesoterodine	Toviaz	muscarinic receptor antagonist	Treatment of overactive bladder	darifenacin, solifenacin, tolterodine	pages 173-174
fosaprepitant (produrg of aprepitant)	Emend	substance P/neurokinin 1 receptor antagonist	Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy	aprepitant	pages 1005
fospropofol (produrg of propofol)	Lusedra	sedative-hypnotic	Monitored anesthesia care sedation	propofol	pages 350-351
gadofosveset	Vasovist	gadolinium-based contrast agent	Magnetic resonance imaging	gadodiamide, gadoteridol
gadoxetate	Requip XL
regadenoson	Lexiscan	adenosine receptor agonist	Pharmacologic stress agent for radionuclide myocardial perfusion imaging	adenosine	page 917
rilonacept (also known as IL-1 Trap)	Arcalyst	interleukin-1 blocker	Treatment of cryopyrin-associated periodic syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome	anakinra	page 672
silodosin	Rapaflo	alpha-1 adrenergic receptor antagonist	Treatment of benign prostatic hyperplasia	prazosin, terazosin, doxazosin, tamsulosin, alfuzosin	pages 269-271
tapentadol	none	m-opioid receptor agonist & norepinephrine reuptake inhibittor	Relief of pain	tramadol	page 566
tetrabenazine	Xenazine	monoamine depletor	Treatment of chorea associated with Huntington´s disease	reserpine	pages 173, 541