Home » TEVA RECEIVES TENTATIVE APPROVAL FOR GENERIC ULTRACET
TEVA RECEIVES TENTATIVE APPROVAL FOR GENERIC ULTRACET
July 20, 2005
The FDA has granted tentative approval to Teva Pharmaceutical's abbreviated new drug application for tramadol and acetaminophen tablets in a 37.5 mg/325 mg dose. Teva's product is the generic equivalent of OrthoMcNeil's Ultracet tablets, which are indicated for short-term management of acute pain. Teva expects final FDA approval for its product once patent litigation involving the drug is resolved, the company said. Total annual sales of the brand product are roughly $338 million, according to Teva.
KEYWORDS Drug Pipeline Alert
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