Medicis Files Solodyn Petition

February 23, 2009
Medicis Pharmaceutical has filed a citizen petition asking the FDA to grant a 30-month stay of approval on certain ANDAs for its acne drug Solodyn. Sandoz, Mylan and Barr, which has been bought by Teva Pharmaceutical Industries, want to make generic versions of Solodyn (minocycline HCl) and have filed separate ANDAs with Paragraph IV certifications. Medicis has sued each drugmaker within 45 days of receiving notice, as mandated by law, and the company maintains it is therefore entitled to the 30-month stay.
Drug Industry Daily