Jan 9 2014
Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis®. Actavis intends to launch the product immediately.
As a "first applicant" to submit a substantially complete ANDA, Actavis is eligible for 180 days of generic market exclusivity.
Micardis® is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure and cardiovascular risk reduction in patients unable to take ACE inhibitors. For the 12 months ending September 30, 2013, Micardis® had total U.S. sales of approximately $274 million, according to IMS Health data.
SOURCE Actavis plc
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