FDAnews Drug Daily Bulletin

Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application for a generic version of Elan’s Verelan PM extended-release capsules, the company announced Aug. 10.

Mylan said it plans to market the drug as 100-, 200- and 300-mg capsules and will begin shipping the product immediately.

Verelan PM (verapamil HCl), a calcium channel blocker indicated for treating hypertension, had U.S. sales of approximately $58 million during the 12-month period that ended June 30, Mylan noted.

Mylan is the only company listed in the FDA Orange Book as having received approval to market generic Verelan PM extended-release capsules.