The license agreement permits Lannett to manufacture and market in the U.S. its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances.
As mandated by the U.S. Food and Drug Administration (FDA), Thalomid® is subject to Risk Evaluation and Mitigation Strategies (REMS) program, which is designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks.
"I congratulate my staff and colleagues for showing the courage and resolve in successfully tackling such a complex project as thalidomide," said Arthur Bedrosian, chief executive officer of Lannett. "We believe our thalidomide will be the first entrant in the U.S. generic market."
Lannett is seeking approval from the FDA of its pending Abbreviated New Drug Application (ANDA) for thalidomide capsules 50 mg, 100 mg, 150 mg and 200 mg, the therapeutic equivalent to the reference listed drug, Thalomid® Capsules, 50 mg, 100 mg, 150 mg and 200 mg, of Celgene Corporation.
Subject to FDA approval of Lannett's ANDA for Thalidomide, the company intends to launch its product under the terms of the license agreement, which are confidential.
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.