Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Perrigo has received final approval from the FDA for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal cream and Suppository, a generic to Monistat -1 Combination Pack. Perrigo expects to begin shipping immediately.
Subscribe to our email newsletter
Monistat -1 OTC product is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation they cause. Perrigo was the first to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson was previously dismissed. Perrigo’s approval includes 180 days of generic marketing exclusivity.
Joseph Papa, chairman and CEO of Perrigo, said: “This is another example of Perrigo’s commitment to innovation by challenging brand patents and bringing new products to market. These innovations help save OTC healthcare consumers more than an estimated $1bn annually.”
Perrigo is a global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products.