Watson Laboratories Inc., a subsidiary of Watson Pharmaceuticals Inc. (WPI), has filed an Abbreviated New Drug Application with the FDA seeking approval to market Nebivolol Hydrochloride Tablets, the generic version of Forest Laboratories' Bystolic.
Bystolic is a beta-adrenergic blocking agent that is approved for the treatment of hypertension.
Forest Laboratories filed suit against Watson on March 13 in the US District Court of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent.
Watson said it might be the first applicant to file an ANDA for the generic version of Bystolic and if approved it will be entitled to 180 days of generic market exclusivity.
by RTT Staff Writer
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