FDA Approves New Strength Of Mallinckrodt’s Pain Drug Exalgo

Mallinckrodt, the pharmaceuticals business of Covidien, Aug. 27 announced that the Food and Drug Administration has approved a 32 mg strength of Exalgo (hydromorphone hydrochloride) extended-release tablets.

Exalgo is indicated for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time, the company, based in Hazelwood, Mo., said.

FDA approved the 8 mg, 12, mg, and 16 mg tablets of Exalgo in March 2010 (8 PLIR 335, 3/12/10), and the supplemental new drug application for the 32 mg tablet was submitted in January.

Covidien said the 32 mg tablet will be ...