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Glenmark receives US FDA tentative approval to market generic Ondansetron HCL |
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20 Sep 2006 |
Received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets: 4 mg (base), 8 mg (base) and 24 mg (base).
MUMBAI, India | Sep 19, 2006 | Glenmark Pharmaceuticals, Inc., USA [GPI], the wholly owned US subsidiary of Glenmark Pharmaceuticals Limited [Glenmark], has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets: 4 mg (base), 8 mg (base) and 24 mg (base). Ondansetron Hydrochloride Tablets are the generic version of GlaxoSmithKline’s Zofram ® Tablets. Ondansetron Hydrochloride belongs to a category of antiemetics and is prescribed to help control nausea and vomiting; the drug had annual sales of about USD 640 million, based on IMS data for the 12 months ending June 30, 2006
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated harmaceutical company headquartered in Mumbai, India. The Company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes.
The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. Its first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively. This compound has recently entered Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, is in Phase II clinical trials in South Africa. Glenmark’s third lead is a compound named GRC 10389, a CB-I receptor antagonist for the treatment of Obesity. This compound is completing pre-clinical studies and is expected to be filed for a Phase I trial in H2 FY07.
The Company has three other programmes across inflammation and pain management scheduled to enter the clinics in FY 2007. [www.glenmarkpharma.com]
For further information, please contact:
Ms. Vaijayanti Karande
Senior Manager [Corporate Communications]
Glenmark Pharmaceuticals Limited
Tel: [+91 22] 6758 9913 | Fax: [+91 22] 6758 9986
Email:
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SOURCE: Glenmark Pharmaceuticals Limited |
