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news.Meitheal Pharmaceuticals, a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox.
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.
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Meitheal licenses Enoxaparin Sodium Injection exclusively through its partnership with Nanjing King-friend Biochemical Pharmaceutical Co., Ltd. (NKF), its majority shareholder. Enoxaparin had annual sales of approximately $616M in the United States, according to IQVIA data as of MAT (Moving Annual Total) October 2019.
“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,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals.
“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, anesthetic, 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.”
Meitheal primarily specializes in the development, manufacture, procurement, and sale of generic injectable pharmaceuticals, with 20 FDA-approved products covering indications for anesthetic, anti-infective, oncolytic and intensive care.
Furthermore, Meitheal has an expanding product portfolio and robust pipeline, including single and multi-dose vials and ready-to-use prefilled syringes. At the end of December 2019, Meitheal will have 39 products in the research and development phase, 19 products under review by the FDA, and 7 products planned to be launched in the first half 2020.
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
Inpatient treatment of acute DVT with or without pulmonary embolism
Outpatient treatment of acute DVT without pulmonary embolism
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI)
Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI)
Source: Company Press Release
