Bridgewater, NJ (USA), March 28, 2017 – Amneal Biosciences has launched levoleucovorin for injection, an AP-rated generic equivalent to Fusilev®, in 50 mg strength. Each 50 mg single-dose vial contains a sterile lyophilized powder consisting of levoleucovorin calcium mixed hydrates (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. The product is latex- and preservative-free. It was approved on February 13, 2017 and is now available through wholesalers, distributors and directly to the trade.
Levoleucovorin for injection is the fifth parenteral medication in the market from Amneal Biosciences following eptifibatide, meropenem, fosphenytoin, furosemide and methylprednisolone sodium succinate. The subsidiary also markets oral solids such as temozolomide capsules for the institutional market.
Annual U.S. sales of Fusilev® were $51 million according to December 2016 IMS market data.
Amneal Biosciences, a wholly-owned subsidiary of Amneal Pharmaceuticals LLC, is dedicated to the commercialization of high-barrier-to-entry generic and specialty pharmaceuticals such as injectables, oncologics, anti-infectives and support care for healthcare providers and patients of all ages. The company’s expertise and focus on the unique needs and logistics of this market ensure the same level of quality and service for healthcare institutions and professionals that Amneal delivers to its retail customers.
Amneal Biosciences is a wholly owned subsidiary of Amneal Pharmaceuticals LLC, a privately-held company headquartered in Bridgewater, New Jersey. Amneal Pharmaceuticals is one of the largest and fastest growing generic pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 4,000 employees in its operations in North America, Asia, Australia and Europe, working together to bring high-quality, affordable medicines to patients worldwide. Amneal has significantly expanded its portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas.
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