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.

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)

New molecular entities approved by the US FDA's Center for Drug Evaluation and Research in 2008

FROM THE FOLLOWING ARTICLE:

2008 FDA drug approvals

Bethan Hughes

Nature Reviews Drug Discovery 8, 93-96 (February 2009)

doi:10.1038/nrd2813

Generic name (Trade name)	Company*	Indication(URL of label information if available)	Properties	Date
Etravirine (Intelence)	Tibotec	HIV-1(http://www.fda.gov/cder/foi/label/2008/022187lbl.pdf)	Non-nucleoside reverse transcriptase inhibitor	18 Jan (P)
Desvenlafaxine (Pristiq)	Wyeth	Major depressive disorder(http://www.fda.gov/cder/foi/label/2008/021992lbl.pdf)	Selective serotonin and noradrenaline reuptake inhibitor	29 Feb (S)
Bendamustine hydrochloride (Treanda)	Cephalon	Chronic lymphocytic leukaemia(http://www.fda.gov/cder/foi/label/2008/022249lbl.pdf)	Mechlorethamine derivative with DNA-alkylating activity	20 Mar (P, O)
Regadenoson (Lexiscan)	CV Therapeutics	Pharmacological stress agent for radionuclide imaging (http://www.fda.gov/cder/foi/label/2008/022161lbl.pdf)	A2A adenosine receptor agonist	10 Apr (S)
Methylnaltrexone bromide (Relistor)	Progenics	Opioid-induced constipation	Peripherally acting  opioid receptor antagonist	24 Apr (S)
Alvimopan (Entereg)	Adolor	To accelerate gastrointestinal recovery following bowel resection surgery(http://www.fda.gov/cder/foi/label/2008/021775lbl.pdf)	Peripherally acting  opioid receptor antagonist	20 May (S)
Difluprednate (Durezol)	Sirion	Inflammation and pain associated with ocular surgery (http://www.fda.gov/cder/foi/label/2008/022212lbl.pdf)	Ocular corticosteroid thought to act by the induction of phospholipase A2 inhibitory proteins	23 Jun (P)
Gadoxetate disodium (Eovist)	Bayer	Gadolinium-based contrast agent(http://www.fda.gov/cder/foi/label/2008/022090lbl.pdf)	Paramagnetic compound	3 Jul (S)
Clevidipine butyrate (Cleviprex)	The Medicines Company	Peri-operative hypertension when oral therapy is not feasible or not desirable	Short-acting dihydropyridine calcium channel antagonist	1 Aug (S)
Tetrabenazine (Xenazine)	Prestwick	Chorea associated with Huntington's disease(http://www.fda.gov/cder/foi/label/2008/021894lbl.pdf)	Monoamine-depleting agent	15 Aug (P, O)
Iobenguane I-123 (AdreView)	GE Healthcare	Radiopharmaceutical agent for the detection of primary or metastatic phaeochromocytoma or neuroblastoma (http://www.fda.gov/cder/foi/label/2008/22290lbl.pdf)	Taken up by the noradrenaline transporter in adrenergic nerve terminals	19 Sep (P, O)
Silodosin (Rapaflo)	Watson	Benign prostatic hyperplasia(http://www.fda.gov/cder/foi/label/2008/022206lbl.pdf)	1 adrenoceptor antagonist	8 Oct (S)
Lacosamide (Vimpat)	Schwarz	Partial-onset seizures in epilepsy (http://www.fda.gov/cder/foi/label/2008/022253lbl.pdf)	Selectively enhances slow inactivation of voltage-gated sodium channels and binds to collapsin response mediator protein 2	28 Oct (S)
Fesoterodine fumarate (Toviaz)	Pfizer	Overactive bladder disorder(http://www.fda.gov/cder/foi/label/2008/022030lbl.pdf)	Competitive muscarinic receptor antagonist	31 Oct (S)
Rufinamide (Banzel)	Eisai	Seizures associated with Lennox–Gastaut syndrome (http://www.fda.gov/cder/foi/label/2008/021911lbl.pdf)	Sodium channel activity modulator	14 Nov (S)
Eltrombopag (Promacta)	GlaxoSmithKline	Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (http://www.fda.gov/cder/foi/label/2008/022291lbl.pdf)	Thrombopoietin receptor agonist	20 Nov (P, O)
Tapentadol hydrochloride‡	Ortho–McNeil–Janssen	Moderate to severe acute pain	opioid receptor agonist and noradrenaline reuptake inhibitor	20 Nov (S)
Fospropofol disodium (Lusedra)	Eisai	Monitored anaesthesia care sedation (http://www.fda.gov/cder/foi/label/2008/022244lbl.pdf)	Prodrug of propofol	12 Dec (S)
Plerixafor (Mozobil)	Genzyme	Autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma (http://www.fda.gov/cder/foi/label/2008/022311lbl.pdf)	CXCR4 antagonist	15 Dec (P, O)
Gadofosveset (Vasovist)	Epix	Gadolinium-based contrast agent	Paramagnetic compound	22 Dec (S)
Degarelix (Firmagon)	Ferring	Advanced prostate cancer (http://www.fda.gov/cder/foi/label/2008/022201lbl.pdf)	Gonadotropin-releasing hormone receptor antagonist	24 Dec (S)
*The company that submitted the original new drug application to the US FDA.‡Trade name not available at the time of going to press. O, FDA orphan designation; P, FDA priority review; S, FDA standard review.