Home » FDA APPROVES TEVA'S PRAVACHOL
FDA APPROVES TEVA'S PRAVACHOL
The FDA has granted final approval to Teva Pharmaceutical to market its version of Bristol-Myers Squibb's cholesterol drug Pravachol, after a federal appeals court lifted the stay it had put on all FDA approvals to market versions of the drug.
The drug's patent expired April 20. Canadian drugmaker Apotex had asked the court to block final approval, claiming Teva's exclusivity has already run out. The appeals court had extended a stay issued by the U.S. District Court for the District of Columbia, which ordered the FDA to hold off issuing final approval for Teva's Pravachol until 5 p.m. April 21, so Apotex would have a chance to appeal the ruling.
KEYWORDS Drug Pipeline Alert
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