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Tentative approval granted for anticancer compound carboplatin.(American Pharmaceutical Partners Inc.)(Brief Article)
2002 JUL 11 - (NewsRx.com & NewsRx.net) -- American Pharmaceutical Partners (APPX) announced it has received tentative approval from the U.S. Food and Drug Administration (FDA) of its abbreviated new drug application (ANDA) for carboplatin injection in single-dose vials containing 50 mg, 150 mg, or 450 mg.
Carboplatin is indicated for initial as well as secondary treatment of ovarian cancer, and is the generic equivalent of Bristol-Myers Squibb's Paraplatin.
The FDA found APP's carboplatin to be safe and effective, however APP will not receive final approval and thus may not market ...
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Source: HighBeam Research, Tentative approval granted for anticancer compound...