FDA accepts Glenmark’s painkiller oxycodone hydrochloride for review
01 Apr 2010
Glenmark Pharmaceuticals Ltd said yesterday the US Food & Drug Administration has accepted for review a new drug application for painkiller oxycodone hydrochloride capsules and liquid solution, which has potential to earn significant revenues for the Indian drug maker.
The application to the FDA was made earlier by Lehigh Valley Technologies, Glenmark's partner in the US.
The painkiller is part of a ''grandfathered products'' list, which includes drugs that have been available in the US prior to the coming into force of the current food and drug regulations in 1938 and still being sold today, despite not being technically approved by the FDA.
Since 2006, the regulator has effected changes in its policy towards ''grandfathered products'', such that once a company sought and received regulatory approval to make and sell these products, it would remove other versions of the drug from the market – even if they had been on sale legally for years.
US sales for oxycodone hydrochloride capsules and liquid solution in the year ending 31 December, 2009, were $16 million as per reports of market research firm IMS Health.
Under the current rules, Glenmark could get an FDA approval within 10 months.
If it were to get a regulatory approval it would boost the company's topline in the financial year starting 1 April 2011, Glenmark chief executive and managing director Glenn Saldanha. Saldhana told CNBC TV18.
