Lupin receives FDA approval for generic SOLODYN tablets

   Date:2011-12-05houhaizhen

Mumbai, Dec 05, 2011: Lupin has announced that its subsidiary, Lupin Pharmaceuticals, has received final approval for its Minocycline hydrochloride extended-release tablets 45 mg, 55 mg, 90 mg and 135 mg strengths as well as tentative approval for its Minocycline HCl extended release tablets 65 mg, 80 mg, 105 mg and 115 mg strengths from the U.S. Food and Drug Administration (FDA) for the company’s Abbreviated New Drug Application (ANDA) to market a generic version of Medicis Pharmaceutical Corporation’s (Medicis) SOLODYN (Minocycline HCI, USP) extended-release tablets.

Solodyn is an oral antibiotic approved to treat only the red, pus-filled pimples of moderate to severe acne in patients 12 years of age and older. Medicis’s Solodyn (Minocycline HCI, USP) Extended-release tablets had sales of USD 750 million as per IMS Sept 2011 data.

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