Perrigo receives FDA approval for generic Monistat-1 Combination Pack
ALLEGAN, Mich. Perrigo on Thursday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream and suppository, a generic to Monistat-1 Combination Pack, and expects to begin shipping immediately.
Annual sales of Monistat-1 totaled approximately $90 million and is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation they cause, Perrigo reported.
Perrigo was the first to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson previously was dismissed. Perrigo's approval included 180 days of generic marketing exclusivity.