Teva Pharmaceutical Industries said yesterday it had won tentative approval from the US Food and Drug Administration for its generic version of J&J's antipsychotic Risperdal (risperidone) Oral Solution.
Tentative approval means that the agency has reviewed the filing and found it acceptable, although full approval cannot be granted until the expiry of patents covering the formulation, or their invalidation through legal action.
Teva said it expects final approval in December 2007, when patents on the branded product expire.
Source: PharmaTimes
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