Monday, June 19, 2017
Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules USP, 100 mg, the therapeutic equivalent to the reference standard drug, Amantadine Hydrochloride Capsules USP, 100 mg, of Sandoz Pharmaceuticals. Previously, the branded version of the product was marketed as Symmetrel® Capsules, 100 mg. For the 12 months ended April 2017, total U.S. sales of Amantadine Hydrochloride Capsules USP, 100 mg, at Average Wholesale Price (AWP) were approximately $25 million, according to IMS.
"The approval of Amantadine Hydrochloride Capsules extends our reach into new areas of the market and is a welcome addition to our product line, especially during the current competitive pricing environment," said Arthur Bedrosian, chief executive officer of Lannett. "While this approval comes too late to benefit fiscal 2017, which ends later this month, we expect to launch the product in time for the coming flu season. We continue to expect additional product approvals."
Bedrosian added that the ANDA for Amantadine Hydrochloride Capsules was approved within 15 months and the bio-equivalency (BE) study related to the product application was successfully performed at its wholly owned pharmacokinetic subsidiary, DarmanTest Laboratories. Amantadine Hydrochloride Capsules represents Lannett's first product approved using DarmanTest to perform the BE study.
Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
