ALPHARMA receives FDA notice regarding Minoxidil.FORT LEE, N.J.--(BUSINESS WIRE)--April 17, 1996--ALPHARMA INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (NYSE NYSE See: New York Stock Exchange : ALO) today announced that its U.S. Pharmaceuticals Division, which manufactures and markets specialty generic pharmaceuticals, received notification from the Food and Drug Administration temporarily suspending its approval 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%, a generic equivalent to Pharmacia & Upjohn's Rogaine(R). The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. stated that this suspension was in direct response to a temporary restraining order temporary restraining order: see injunction. issued against the FDA in a lawsuit filed by Pharmacia & Upjohn challenging the FDA's denial of three years of marketing exclusivity for non-prescription Rogaine. The temporary restraining order required the FDA to suspend the effective date of all regulatory approvals previously granted and to refrain from issuing any new approvals for the product. The court has set a hearing on Upjohn's motion for April 25, 1996. Barre-National, Inc., a unit of ALPHARMA's U.S. Pharmaceuticals Division, was one of three companies that received approval recently to begin selling the generic equivalent of the product. While ALPHARMA was not directly named in the lawsuit its interests are affected and the Company is, therefore, aggressively pursuing its legal remedies A legal remedy is the means by which a court of law, usually in the exercise of civil law jurisdiction, enforces a right, imposes a penalty, or makes some other court order to impose its will. In Commonwealth common law jurisdictions and related jurisdictions (e.g. to address this situation. The Company has been cooperating with the FDA in the agency's efforts to clarify and respond to the Pharmacia & Upjohn action. The FDA assured ALPHARMA that it believes its decision to deny three years of marketing exclusivity for Rogaine was proper and that it intends to vigorously defend its decision at the April 25 hearing and, if necessary, thereafter. ALPHARMA is a multinational pharmaceutical company developing, manufacturing and marketing specialty generic and proprietary human pharmaceuticals 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 Antibiotics Definition Antibiotics may be informally defined as the subgroup of anti-infectives that are derived from bacterial sources and are used to treat bacterial infections. , and is recognized worldwide as a leading providing of animal health feed additives for poultry poultry, domesticated fowl kept primarily for meat and eggs; including birds of the order Galliformes, e.g., the chicken, turkey, guinea fowl, pheasant, quail, and peacock; and natatorial (swimming) birds, e.g., the duck and goose. and livestock, and vaccines for farmed fish. CONTACT: Iris Daniels ALPHARMA INC. 201/947-7774 or Investor Contact: Donna Stein/Courtney Levi Morgen-Walke Associates, Inc. 212/850-5600 or Press Contact: Michelle Zawrothy Morgen-Walke Associates, Inc. 212/850-5631 |
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