Watson Confirms Filing of Abbreviated New Drug Application for Generic Enablex(R)
Tue, 04/28/2009 - 4:47am
CORONA, Calif., April 28 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals,Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmedthat it has filed an Abbreviated New Drug Application (ANDA) with the U.S.Food and Drug Administration seeking approval to market its darifenacinhydrobromide extended-release 7.5 mg and 15 mg product prior to the expirationof a patent owned by Novartis AG. Watson's darifenacin hydrobromideextended-release product is the generic version of Novartis AG's Enablex(R)which is indicated for the treatment of overactive bladder with symptoms ofurge urinary incontinence, urgency and frequency. Novartis AG filed suit against Watson on April 24, 2009 in the U.S.District Court for the District of Delaware seeking to prevent Watson fromcommercializing its products prior to expiration of U.S. patent number6,106,864. Novartis AG's suit was filed under the provisions of the HatchWaxman Act, resulting in a stay of final FDA approval of Watson's ANDA for upto 30 months or until final resolution of the matter before the court,whichever occurs sooner.