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Dec 06, 2010, 12.30 PM IST | Source: Moneycontrol.com

Glenmark, LVT announce approval of 2 NDAs

Glenmark and Lehigh Valley Technologies jointly announce the approval by the FDA of two New Drug Applications (NDAs) for a line of controlled substance products containing Oxycodone, signing a new agreement between Glenmark and LVT.

Glenmark, LVT announce approval of 2 NDAs

Glenmark Generics Inc, USA (Glenmark), the United States subsidiary of Glenmark Generics Ltd, and Lehigh Valley Technologies (LVT) jointly announce the approval by the Food and Drug Administration of two New Drug Applications (NDAs) for a line of controlled substance products containing Oxycodone Hydrochloride (Oxycodone), along with their signing of a new Supply and Marketing Agreement between Glenmark and LVT.

The two approved NDAs provide Glenmark and LVT with manufacturing and distribution rights to the only FDA approved Oxycodone immediate release capsules and oral solution currently available in the United States.

LVT will be responsible for the manufacture of the Oxycodone product line for Glenmarks exclusive marketing and distribution in generic form. LVT will retain exclusive marketing rights to the branded version of the Oxycodone product line. LVT will also retain exclusive marketing rights to additional strengths of the Oxycodone product line in both generic and branded forms, including but not limited to Oxycodone Hydrochloride HCl 5mg/5Ml oral solution.

According to IMS Health for the 12 month period ending September 2010, Oxycodone Hydrochloride immediate release oral solid capsule and liquid formulations represent total market sales of USD 13 million.

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