WASHINGTON (dpa-AFX) - Actavis plc (ACT) announced it has received final approval from the U.S. FDA on its Abbreviated New Drug Application for a generic version of Mallinckrodt Inc.'s Exalgo (Hydromorphone Hydrochloride Extended-release Tablets 8 mg, 12 mg and 16 mg). The company intends to begin shipping its product shortly and believes that it may be entitled to marketing exclusivity.
Exalgo is indicated 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.
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