US FDA accepts Glenmark's NDA for pain killer drug
Drug firm Glenmark today said US Food and Drug Administration (FDA) has accepted its new drug application for pain killer oxycodone hydrochloride capsules.business Updated: Mar 31, 2010 15:56 IST
Drug firm Glenmark today said US Food and Drug Administration (FDA) has accepted its new drug application for pain killer oxycodone hydrochloride capsules.
"FDA in a letter to the company indicated it has completed the filing review and has begun reviewing the application for oxycodone hydrochloride," Glenmark said in a statement.
The company had filed the new drug application (NDA) for oxycodone hydrochloride capsules in order to make it eligible for continued sales in the US to meet the criteria set by the health regulator, which requires old drugs to be approved by it.
The US FDA had started a new policy in June 2006, for transitioning of grandfathered products that were manufactured and sold in the US prior to its existence, to approved products.
"Glenmark and Lehigh Valley Technologies (LVT) have taken a proactive approach towards unapproved products and are working closely with the FDA to ensure successful and timely approval of the application," the company said.
Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once a new drug application is accepted for filing, it is expected that the FDA will complete review and provide an action letter with respect to the NDA within 10 months following its submission, it added.
Glenmark Generics Ltd, a subsidiary of Glenmark Pharmaceuticals, submitted the NDA for oxycodone hydrochloride drug both in capsule and liquid solutions form in association with its partner LVT.
In 2006, Glenmark and LVT entered into an exclusive partnership, under which the latter would manufacture both oral solid and liquid controlled substances for the other partner to market and distribute in the United States.
The pain killer drug has reported total sales of USD 16 million in the twelve-month period ending December 2009, Glenmark said quoting market research firm IMS.