HomeGlenmark Generics announces New Drug Applications for Oxycodone Hydrochloride Capsules & Liquid Soln
Date: 31 March 2010
Press Release For Immediate Release
Glenmark Generics announced New Drug Applications for Oxycodone Hydrochloride Capsules and Liquid Solution
· NDAs submitted by their partner Lehigh Valley Technologies (LVT) to the US-FDA
Mumbai, March 31, 2010 – Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), today announced that New Drug Applications (NDA’s) for Oxycodone Hydrochloride Capsules, and Liquid Solution have been previously submitted by their partner Lehigh Valley Technologies (LVT) to the USFDA. The FDA in a letter to the company indicated it has completed the filing review and begun reviewing the application for Oxycodone Hydrochloride.
Total sales for Oxycodone Hydrochloride Capsules and Liquid Solution in the twelve month period ending December 2009 were USD 16 million as reported by IMS Health.
Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once an NDA is accepted for filing, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA.
In light of FDA’s recent initiative regarding “grandfathered/unapproved, products”, that is, products manufactured and sold in the United States prior to the passage of the Food Drug and Cosmetic Act in 1938, Glenmark and LVT have taken a proactive approach towards this unapproved product and are working closely with the FDA to ensure successful and timely approval of the application.
In 2006, Glenmark and LVT entered into an exclusive partnership whereby LVT would manufacture both oral solid and liquid controlled substances for Glenmark to market and distribute in the United States. Over the course of this relationship Glenmark has successfully launched and gained market share for this basket of CII(Class II) products.
About Glenmark Generics limited.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.
Disclaimer
“Glenmark Generics Limited (“Company”) is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI. The Draft Red Herring Prospectus is available on the website of SEBI at www.sebi.gov.in and the respective websites of the BRLMs at www.enam.com and www.kmcc.co.in.
Investors should note that investment in equity shares involves a high degree of risk and for details relating to the same, see the section titled “Risk Factors” of the aforementioned Draft Red Herring Prospectus.”
This press release is not an offer of securities for sale in the United States or elsewhere. The shares of Glenmark Generics Limited are not being registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration. There will be no public offering of the shares in the United States.
NOT FOR PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA
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