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Glenmark receives US FDA approval for Ondansetron IR and Ondansetron ODT tablets |
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30 Jun 2007 |
Glenmark Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base) and Ondansetron Orally Disintegrating Tablets 4mg & 8mg
MUMBAI, India | June 29, 2007 | Glenmark Pharmaceuticals Ltd. [Glenmark], a research-based pharmaceutical company, headquartered in Mumbai (India), has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base) and Ondansetron Orally Disintegrating Tablets 4mg & 8mg
Ondansetron HCl Tablets are the generic version of GlaxoSmithKline's Zofran(R) Tablets. It is a popular anti-emetic, commonly used by cancer patients.
Ondansetron HCl Tablets had U.S. sales of approximately $744 million for the same strengths for the 12-month period ending March 31, 2007, according to IMS Health.
Glenmark is manufacturing the finished dose formulation at its USFDA approved manufacturing facility in Goa, India. Glenmark’s US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI] will start marketing the product in the US.
With this approval, GPI now has a portfolio of 18 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.
About Glenmark Pharmaceuticals Inc., USA [GPI]
Glenmark’s US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI], was established in 2003 to enter into the world's largest pharmaceutical market. GPI is responsible for sales and marketing of generic drug formulations in the USA as well as APIs to customers in the regulated markets. GPI closed last Fiscal year with sales of USD 50 Mn from its formulations business.
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc].
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, Diabetes and Oncology.
Glenmark’s 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, in two landmark deals. Oglemilast is presently undergoing.
Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, is undergoing Phase II clinical trials in Europe. Glenmark has three other programmes across obesity, inflammation and pain management at the pre-clinical stages; all of which should enter the clinics in by H1 FY 2008. [www.glenmarkpharma.com]
SOURCE: Glenmark Pharmaceuticals Ltd. |
