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news.Mylan said that its subsidiary Matrix Laboratories received final approval from FDA for its abbreviated new drug application (ANDA) for Minocycline Hydrochloride extended release (ER) Tablets, 45 mg, 90 mg and 135 mg, and entered into settlement and license agreements with Medicis Pharmaceuticals relating to Minocycline ER.
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Minocycline ER is the generic version of Solodyn ER, a treatment for acne, sold by Medicis. Solodyn is a tetracycline class antibiotic medicine that contains minocycline. It fights bacteria in the body.
Solodyn is used for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 12 years and older. It does not demonstrate any effect on non-inflammatory lesions.
Follwing the settlement and license agreements Mylan has agreed to cease additional distribution.
As per the terms of the agreement, Medicis is expected to release Mylan from any liability related to the prior sales of this product, and Mylan is expected to have the right to market Minocycline ER in the US beginning in November 2011 or earlier under certain circumstances.