Perrigo Co. announced that it has received U.S. Food and Drug Administration approval for its New Drug Application (NDA) for testosterone gel 1%. Perrigo's NDA included a bioequivalence study that compared its product to AbbVie's AndroGel 1%.
AndroGel® 1% (testosterone gel 1%) is indicated to treat adult males who have low or no testosterone. Annual sales were approximately $705 million annually, as measured by Symphony Health.
Ther-Rx Corp., a women's health-focused pharmaceutical company and subsidiary of K-V Pharmaceutical Company (OTCQB Marketplace: KVPHA/KVPHB), and Perrigo Company (Nasdaq: PRGO; TASE) announced today that Gynazole-1® (Butoconazole Nitrate Vaginal Cream USP, 2%), indicated for the local treatment of yeast infections (vulvovaginal candidiasis infections caused by Candida) in non-pregnant women1, is now available for prescribing. Gynazole-1 is available at major national and regional retail pharmacy chains across the country.
The Perrigo Company announced that it has begun commercial shipments of betamethasone valerate foam 0.12%, the generic equivalent of Luxiq® Foam, consistent with the date certain launch settlement previously announced. Cobrek Pharmaceuticals, Inc., which was recently acquired by Perrigo, was first to file, making the product eligible for 180 days of marketing exclusivity. Perrigo is entitled to receive 100% of the profits from net sales of the product due to the Cobrek acquisition.
The product, from the company’s partner firm Cobrek Pharmaceuticals Inc., is indicated for treatment of scalp psoriasis.
Perrigo Co. announced that its partner, Cobrek Pharmaceuticals, Inc., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq Foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013, consistent with the date certain launch settlement. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.
The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor).
Perrigo Company announced that it has received final approval from the U.S.