ALPHARMA ANNOUNCES TWO FDA APPROVALS - MINOXIDIL TOPICAL SOLUTION AND MICONAZOLE NITRATE VAGINAL CREAM.FORT LEE, NJ--(BUSINESS WIRE)--April 8, 1996--ALPHARMA INC. (NYSE NYSE See: New York Stock Exchange :ALO) today announced that its U.S. Pharmaceuticals Division, which manufactures and markets specialty generic pharmaceuticals, received approval from the Food and Drug Administration to manufacture and market Minoxidil Minoxidil Definition Minoxidil is a drug available in two forms to treat different conditions. Oral minoxidil is used to treat high blood pressure and the topical solution form is used to treat hair loss and baldness. Topical Solution, 2% and Miconazole Nitrate Vaginal Cream, 2%. Minoxidil Topical Solution is the generic equivalent of the branded product, Rogaine(R). Until February 9, 1996, Rogaine was sold as a prescription product and had annual sales of approximately $100 million. Now, as an over-the-counter product, the market is anticipated to experience rapid growth. Minoxidil Topical Solution, indicated for the treatment of male pattern baldness male pattern baldness n. A progressive, diffuse loss of scalp hair in men that begins in the twenties or early thirties, depends on the presence of the androgenic hormone testosterone, and is caused by a combination of genetic and hormonal factors. , will be marketed by ALPHARMA's U.S. Pharmaceuticals Division under its Barre(R) label and store brand labels, packaged in a single 60 mL bottle and a twin-pack. Shipments are expected to commence during the second quarter. Miconazole miconazole /mi·con·a·zole/ (mi-kon´ah-zol) an imidazoleantifungal agent used as the base or the nitrate salt against tinea and cutaneous or vulvovaginal candidiasis. Vaginal Cream is the generic equivalent of the branded product, Monistat(R)-7 Vaginal Cream, which along with other competitive products, currently has annual revenues in excess of $100 million. The product, indicated for the treatment of vaginal yeast infections and the external itching and irritation associated with such yeast infections, will be available in packages with seven disposable applicators or a single reusable applicator ap·pli·ca·tor n. An instrument for applying something, such as a medication. applicator, n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end. . Miconazole Vaginal Cream will be marketed by ALPHARMA's U.S. Pharmaceuticals Division under its NMC(R) label and store brand labels, along with its Miconazole Vaginal Suppositories suppositories, n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum. and Clotrimazole clotrimazole /clo·trim·a·zole/ (klo-trim´ah-zol) an imidazole derivative used as a broad-spectrum antifungal agent. clo·trim·a·zole n. Vaginal Cream. The approval of Miconazole Vaginal Cream positions ALPHARMA as the only company with ANDA ANDA abbr. abbreviated new drug application approvals for all three products and solidifies ALPHARMA's leadership position in the $240 million feminine yeast infection treatment market. Both Minoxidil Topical Solution and Miconazole Vaginal Cream are significant additions to ALPHARMA's consumer products line and strengthens its U.S. Pharmaceuticals Division as a leader in providing Rx to OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). "switched" products to the marketplace. ALPHARMA is a multinational pharmaceutical company developing, manufacturing and marketing specialty generic and proprietary human pharmaceutical and animal health products. ALPHARMA is the largest manufacturer of generic liquid and topical pharmaceuticals in the U.S., has an established and growing market position in finished pharmaceuticals in Europe and the Far East, is a basic manufacturer of important specialty antibiotics, and is recognized worldwide as a leading provider of animal health feed additives for poultry and livestock, and vaccines for farmed fish. CONTACT: ALPHARMA INC. Iris Daniels 201/947-7774 or Investor Contact: Morgen-Walke Associates, Inc. Donna Stein/Courtney Levi 212/850-5600 or Press Contact: Morgen-Walke Associates, Inc. Michelle Zawrotny 212/850-5631 |
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