Lannett signs settlement and license agreement with Celgene.
M2 PHARMA-November 1, 2017-Lannett signs settlement and license agreement with Celgene
(C)2017 M2 COMMUNICATIONS
United States-based Lannett has signed a settlement and license agreement with United States-based Celgene.
It was reported yesterday that the contract resolves patent infringement litigation in the United States related to Celgene's Thalomid.
The license agreement approves Lannett to produce and market its generic thalidomide product in the United States as of 1 August 2019 or earlier under certain circumstances. As mandated by the US Food and Drug Administration (FDA), Thalomid is subject to Risk Evaluation and Mitigation Strategies program, which is designed and implemented during the commercialisation of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks. Subject to FDA approval of Lannett's Abbreviated New Drug Application (ANDA) for Thalidomide, the company intends to launch its product under the terms of the license agreement, which are confidential.
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|Date:||Nov 1, 2017|
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