FDA Approves Perrigo’s Generic Monistat

Perrigo Co. June 3 announced that the Food and Drug Administration has approved its abbreviated new drug application (ANDA) for a generic version of Johnson & Johnson’s Monistat (miconazole nitrate vaginal cream and suppository).

This over-the-counter product is indicated for the treatment of vaginal yeast infections, the Allegan, Mich.-based company said. Perrigo expects to begin shipping the product immediately.

Perrigo said it was the first to file an ANDA containing a paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson was dismissed in 2008 (6 PLIR 1085, 9/26/08). Being the first to file with ...