PHILADELPHIA — Lannett Co. has received Food and Drug Administration approval for niacin extended-release tablets 500 mg and 1,000 mg and amantadine hydrochloride capsules 100 mg.
Lannett said Monday that its niacin product is a generic version of Niaspan ER tablets (500 mg and 1,000 mg) from AbbVie Inc. The medication is indicated to raise HDL (“good”) cholesterol and lower LDL (“bad”) cholesterol and triglycerides along with a doctor-recommended diet and exercise.
U.S. sales of niacin ER tablets (500 mg and 1,000 mg) at average wholesale price totaled about $152 million for the 12 months through April 2017, according to IMS Health data reported by Lannett.
“Niacin extended-release tablets is our second approval in recent days, setting the stage as we head into fiscal 2018,” stated Arthur Bedrosian, chief executive officer of Lannett. “This approval comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals, and will further diversify our product offering. We anticipate launching our product shortly and continue to believe additional approvals are forthcoming.”
Lannett announced FDA clearance of its amantadine hydrochloride capsules (100 mg) on Friday. The company said the product is a therapeutic equivalent of the reference standard drug, Amantadine Hydrochloride Capsules 100 mg from Sandoz Inc. Previously, the branded version of the product was marketed as Symmetrel capsules (100 mg).
Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. The medication also is used for treating Parkinson’s disease and Parkinson’s-like symptoms as well as drug-induced extrapyramidal reactions.
Bedrosian noted that the Abbreviated New Drug Application (ANDA) for amantadine hydrochloride capsules was approved within 15 months, and the bioequivalency (BE) study related to the product application was successfully performed at Lannett’s pharmacokinetic subsidiary, DarmanTest Laboratories. The medication represents Lannett’s first product approved using DarmanTest to perform the BE study.
“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,” he added. “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.”
In the United States, amantadine hydrochloride capsules (100 mg) had sales of approximately $25 million for the 12 months ended in April, Lannett said, citing IMS Health data.