PITTSBURGH — Mylan Pharmaceuticals Inc. has started shipment of minocycline hydrochloride extended-release tablets, indicated for the treatment of acne.
Mylan said its Matrix Laboratories subsidiary received final approval on July 20 from the Food and Drug Administration for its abbreviated new drug application (ANDA) for minocycline ER tablets in doses of 45 mg, 90 mg and 135 mg.
The medication is the generic version of Solodyn ER, sold by Medicis Pharmaceuticals Corp.
Mylan also announced that it has reached settlement and license agreements with Medicis resolving patent litigation relating to minocycline ER, and the company has ceased additional distribution. According to the terms of the agreements, Medicis will release Mylan from any liability related to the prior sales of the product, and Mylan will have the right to market minocycline ER in the United States beginning in November 2011 or earlier under certain circumstances, Mylan reported.
Minocycline ER had U.S. sales of about $496 million for the 12 months ending March 31, according to IMS Health data cited by Mylan.
