Research & Development
US FDA grants approval to Meitheal Pharmaceuticals' Enoxaparin Sodium Injection
9 December 2019 -

The US Food and Drug Administration (FDA) has granted approval to Meitheal Pharmaceuticals, a fully integrated generic injectables company, for its Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox, it was reported on Friday.

The company licenses Enoxaparin Sodium Injection exclusively through its collaboration with Nanjing King-friend (NKF) Biochemical Pharmaceutical Co Ltd, its majority shareholder. Enoxaparin Sodium Injection, USP is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness.

Tom Shea, chief executive officer of Meitheal Pharmaceuticals, said, 'We are excited to be making such progress in our mission to bridge major gaps in healthcare by guaranteeing quality, affordable generic injectables that address an array of patient needs by offering a vertically integrated enoxaparin portfolio in the US. Reflecting on this past year and looking ahead to 2020, we are pleased to have closed our investment transaction with NKF, launched our heparin product, and in total, 20 FDA-approved products covering anti-infective, anaesthetic, oncolytic and intensive care. We have an expanding product portfolio as we prepare to launch enoxaparin and look forward to bringing other injectable products to market next year.'



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