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December 5, 2019

FDA Approves Enoxaparin Sodium Injection in the United States

December 5, 2019—Meitheal Pharmaceuticals, a generic injectable pharmaceuticals company based in Chicago, Illinois, announced that the FDA has approved the company's enoxaparin sodium injection exclusively through its partnership with Nanjing King-friend Biochemical Pharmaceutical Co., Ltd., its majority shareholder.

Enoxaparin sodium injection is a low-molecular-weight heparin indicated for several preventative and acute deep vein thrombosis presentations, as well as for cardiac uses, including:

  • Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction
  • Treatment of acute ST-segment elevation myocardial infarction managed medically or with subsequent percutaneous coronary intervention

Meitheal noted that by the end of December 2019, it will have 39 products in the research and development phase, 19 products under review by the FDA, and seven products planned to be launched in the first half of 2020.

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