Faulding receives tentative FDA Approval for Acyclovir injection.ELIZABETH, N.J.--(BUSINESS WIRE)--April 11, 1997-- Seeks share of $74 million market for antiviral drug Faulding Inc.'s wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , Faulding Pharmaceutical Co., has received tentative approval from the Food and Drug Administration to market 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, the generic version of Zovirax(R) brand of acyclovir sodium sterile powder, which in 1996 had sales of approximately $74 million. Final 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. approval is expected upon expiration of the brand's patent on April 22. Acyclovir injection contains acyclovir, an antiviral drug active against herpes viruses. "Our product is a sterile solution and does not require reconstitution with sterile water. In contrast, the brand product Zovirax(R) must first be dissolved in sterile water prior to use, an extra step to be performed by the health care provider," explained Richard F. Moldin, president and chief executive officer of Faulding Inc. The acyclovir injection approval is the fifth FDA approval received by Faulding Inc. this calendar 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 and preserved and unpreserved presentations of atracurium besylate injection. On March 31 Purepac received FDA approval to market 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, a product that is not scheduled for commercial launch at this time due to extreme erosion in the market price for that product. 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." Note: Zovirax(R) is a registered trademark of Glaxo Wellcome. CONTACT: Faulding Inc. Andrew M. Berdon, 908/527-9100 |
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