Watson Pharmaceuticals Inc. (WPI) confirmed that its subsidiary, Watson Laboratories Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Hydromorphone Hydrochloride Extended-release Tablets, 8 mg, 12 mg, and 16 mg.
Watson's Hydromorphone Hydrochloride Extended-release Tablets are a generic version of Mallinckrodt Inc.'s Exalgo tablets, which are indicated for once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
Earlier this month, Mallinckrodt filed suit against Watson in the United States District Court for the District of New Jersey, seeking to prevent Watson from commercializing its product prior to the expiration of its U.S. Patent.
Mallinckrodt's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until April 29, 2013, or until final resolution of the matter before the court, whichever occurs sooner.
by RTT Staff Writer
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