FDA Accepts Glenmark's Review Plea for Painkiller
BANGALORE -- Glenmark Pharmaceuticals Ltd. said Wednesday the 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 application to the FDA was made earlier by Glenmark's partner in the U.S., Lehigh Valley Technologies.
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.
Since 2006, the regulator has changed its policy towards these "grandfathered products". Once a company seeks and receives regulatory approval to make and sell these products, it must remove other versions of the drug from the market--even if they have been on sale, legally, for years.
U.S. sales for oxycodone hydrochloride capsules and liquid solution in the year ending December 31, 2009, were $16 million as reported by market research firm IMS Health.
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.
Mr. Saldanha said also that the drug could generate "pretty substantial" operating margins.
April 07, 2010