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Actavis files Abbreviated New Drug Application to market Isotretinoin Capsules.

M2 PHARMA-November 1, 2013-Actavis files Abbreviated New Drug Application to market Isotretinoin Capsules(C)2013 M2 COMMUNICATIONS

Actavis plc (NYSE: ACT), a global, integrated specialty pharmaceutical company, has filed an Abbreviated New Drug Application to market Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg with the United States Food and Drug Administration, it was reported yesterday.

The company's Abbreviated New Drug Application product is a generic version of Ranbaxy Inc.'s Absorica(r), which is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

A file was suited against Actavis on October 29, 2013, in the US District Court for the District of New Jersey, seeking to prevent Actavis from commercialising its Abbreviated New Drug Application product prior to the expiration of U.S. Patent No. 8,367,102 by Cipher Pharmaceuticals Inc, Galephar Pharmaceutical Research Inc, Ranbaxy Inc and Ranbaxy Pharmaceuticals Inc.

According to the available information, Actavis believes it may be a 'first applicant' to file an Abbreviated New Drug Application for the generic version of Absorica(r), and, should its Abbreviated New Drug Application be approved, may be entitled to 180 days of generic market exclusivity.

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Publication:M2 Pharma
Date:Nov 1, 2013
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