Faulding Inc. Receives FDA Approval for Pentoxifylline Extended-Release Tablets.ELIZABETH, N.J.--(BUSINESS WIRE)--July 9, 1997-- -- Participates in Formation of Generic Market for $172 Million Cardiovascular Drug -- Faulding Inc.'s wholly-owned subsidiary Purepac Pharmaceutical Co., has received approval from 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. to market pentoxifylline extended release tablets 400 mg, it was announced today by Richard F. Moldin, president and chief executive officer of Faulding Inc. "Our 400 mg pentoxifylline extended-release tablets are the generic equivalent of Trental(R) marketed by Hoechst Marion Roussel Inc., which had reported brand sales of $172 million in 1996. Pentoxifylline extended-release tablets are indicated for the treatment of chronic occlusive arterial disease of the limbs," said Moldin. While Faulding's approval is joined by those of other competitors, Faulding will be participating in the formation of the generic market for pentoxifylline, which has been off patent since April of 1997. The company will commence commercial shipment of the product immediately. "Pentoxifylline extended-release tablets are difficult to formulate, and Faulding's expertise in the area of modified-release technology provided us with a distinct advantage in gaining approval of this product," added Moldin. The pentoxifylline approval is the seventh FDA approval received by Faulding Inc. this calender CALENDER. An almanac. Julius Caesar ordained that the Roman year should consist of 365 days, except every fourth year, which should contain 366, the additional day to be reckoned by counting the twenty-fourth day of February (which was the 6th of the calends of March) twice. year. Since January 1, Faulding Inc. has announced approvals for etodolac etodolac /eto·do·lac/ (e-to-do´lak) a nonsteroidal antiinflammatory drug used as an analgesic and antiinflammatory, especially to treat arthritis. e·to·do·lac n. tablets, preserved and unpreserved presentations of atracurium besylate injection, captopril captopril /cap·to·pril/ (kap´to-pril) an angiotensin-converting enzyme inhibitor used in the treatment of hypertension, congestive heart failure, and post–myocardial infarction left ventricular dysfunction. tablets, acyclovir acyclovir /acy·clo·vir/ (a-si´klo-ver) a synthetic purine nucleoside with selective activity against herpes simplex virus; used as the base or the sodium salt in the treatment of genital and mucocutaneous herpesvirus infections. injection and acyclovir tablets. Faulding Inc. develops, manufactures and markets human pharmaceuticals and medical devices. The shares of Faulding Inc. are traded on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on under the symbol "FAUL." -0- Note: Trental(R) is a registered trademark of Hoechst AG. CONTACT: Faulding Inc. Andrew Berdon, 908/527-9100 |
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