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.
|
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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.
|
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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.
|
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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.
|
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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.
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