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Drug Forum



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FDA Approved Glenmark Painkiller Product 
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Joined: Tue Nov 25, 2008 12:27 pm
Posts: 4
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U.S. Food & Drug Administration has accepted for review a new drug application for painkiller oxycodone hydrochloride capsules and liquid solution, which could potentially be a significant revenue earner for the Indian drug maker. The painkiller is part of a "grandfathered products" list, which includes drugs that have been available in the U.S. before the current food and drug regulations came into force in 1938 and which are still being sold today, despite not technically having the FDA approval. Under current rules, Glenmark could get an FDA approval within 10 months. If the company is able to get a regulatory approval, the drug could boost the company's topline in the financial year starting April 1, 2011, Glenmark Chief Executive and Managing Director Glenn Saldanha told television news channel CNBC-TV18. Glenmark Pharmaceuticals Ltd. said on Wednesday


Thu Apr 08, 2010 1:09 pm
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