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www.aurobindo.com |
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Hyderabad, 27th September, 2005 |
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US FDA GRANTS TENTATIVE
APPROVAL FOR AUROBINDO'S SERTRALINE |
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Aurobindo Pharma Limited is
pleased to announce that U.S. Food Drug
Administration (US FDA) has tentatively approved
its Sertraline Hydrochloride ANDA for Tablets 25
mg (base), 50 mg (base) and 100 mg (base). |
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Aurobindo will be able to market
this product in the US market after the expiry
of the Setraline hydrochloride product patent
and also upon final approval from USFDA. It is
one of the important approvals for Aurobindo in
terms of its R&D capabilities as this tentative
approval received from USFDA, termed its generic
drug product to be bio-equivalent and have the
same therapeutic effect to the innovator
product, namely Zoloft of Pfizer Inc. |
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Aurobindo is already selling
three formulations in the US and the strategy is
kept right to penetrate the US market. |
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About Aurobindo Pharma Limited: |
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Aurobindo Pharma Limited (www.aurobindo.com),
headquartered at Hyderabad, India, manufactures
generic pharmaceuticals and active
pharmaceutical ingredients. The company has
received approvals for several facilities from
leading regulatory agencies like US FDA, UK MHRA,
WHO, Health Canada, MCC South Africa. The
company’s robust product portfolio is spread
over 6 major therapeutic/product areas
encompassing (Antibiotics, Anti-Retrovirals,
CVS, CNS, Gastroenterologicals, and Anti-Allergics)
around 65 APIs in the non-antibiotics and 55
APIs in the antibiotic segment. The Company is
marketing these products globally, in over 100
countries. |
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PRESS
ROOM
