Barr Pharmaceuticals (BRL) Receives FDA Approval for Generic ZOLOFT
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Barr Pharmaceuticals, Inc. (NYSE: BRL) and its subsidiary PLIVA d.d announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Sertraline Hydrochloride Tablets, 25 mg, 50 mg and 100 mg, generic versions of Pfizer Inc.'s (NYSE: PFE) ZOLOFT Tablets.
The FDA issued final approval today following the expiration of Teva Pharmaceuticals' 180-days of marketing exclusivity, as provided for under the Hatch-Waxman Act. The Company intends to launch its product immediately.
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