HomeGlenmark Generics receives tentative approval from the USFDA for Fluocinonide 0.1% cream
Date: 24 July 2010
Press Release For Immediate Release
Glenmark Generics receives tentative approval from the USFDA for Fluocinonide 0.1% cream
July 23, 2010: Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics Ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Fluocinonide 0.1% cream, the generic version of Medicis's Vanos® cream.
Vanos® cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older and generated sales of USD 30 million for the 12 month period ending March 2010, according to IMS Health. The Company previously announced the settlement of all litigation between Glenmark and Medicis Pharmaceutical Corporation relating to the patent actions regarding Fluocinonide. Under the terms of the Settlement Agreement, Glenmark will be able to market and distribute its generic version of Vanos® cream under license from Medicis as early as December 2013, or earlier in certain circumstances
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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