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.