Watson Confirms FDA Denies Appeal Related to Prochieve® NDA for the Prevention of Preterm Birth
PARSIPPANY, N.J., Oct. 26, 2012 /PRNewswire/ — Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that the U.S. Food and Drug Administration (FDA) denied the Company’s Formal Dispute Resolution Request (FDRR) related to its pending New Drug Application (NDA) for Prochieve for the prevention of preterm birth in women with a short cervical length. The Company said it intends to review possible options related to the continued pursuit of the NDA. Watson filed its FDRR in August of 2012.
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SOURCE Watson Pharmaceuticals, Inc.