Barr Pharmaceuticals (BRL) Receives Tentative FDA Approval for Generic Risperdal
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Barr Pharmaceuticals, Inc. (NYSE: BRL) announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Janssen Pharmaceutica Products, L.P.'s Risperdal Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
A tentative approval reflects FDA's determination that a generic product satisfies the requirements for final approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
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