www.fdanews.com/articles/97428-mylan-wins-approval-for-generic-verelan-pm
Mylan Wins Approval for Generic Verelan PM
August 20, 2007
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.