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Monday 30 August 1999
IVAX gets OK for Cimetidine
The Food and Drug Admini-stration has approved IVAX Corp.'s ANDA for cimetidine tablets USP in 200 mg dose form.
Cimetidine is indicated for the treatment of heartburn associated with acid indigestion and sour stomach, and is the generic equivalent of SmithKline Beecham's Tagamet(r) HB 200 tablets. The drug, which is sold as an over-the-counter product, will be marketed by IVAX's wholly owned subsidiary, Zenith Goldline Pharmaceuticals Inc.
The FDA also has tentatively approved the company's ANDAs for ranitidine tablets in 75 mg dose form and buspirone hydrochloride tablets in 5 mg, 10 mg and 15 mg dose forms. Ranitidine is the generic equivalent of Glaxo Wellcome's Zantac(r) 75; Buspirone hydrochloride is the generic equivalent of Bristol-Myers Squibb's Buspar(r), and is indicated for the management of anxiety disorders.