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FDA Approves Sagent’s Sumatriptan Succinate Injection and Rocuronium Bromide Injection

By Pharmaceutical Processing | August 2, 2010

Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced two FDA approvals — sumatriptan succinate injection and rocuronium bromide injection. Sumatriptan succinate injection (sumatriptan) will be available in 6 mg per 0.5 mL latex-free vials. Rocuronium bromide injection will be available in latex-free vials of 50 mg per 5 mL and 100 mg per 10 mL. According to 2009 IMS data, the U.S. market for injectable sumatriptan approximated $22 million and $59 million for rocuronium.

“The addition of sumatriptan and rocuronium vials further expands our portfolio of injectable products,” said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent.

“Migraine and cluster headaches are serious medical conditions and sumatriptan is a frequently prescribed medication for the treatment of these afflictions while rocuronium use is vital in many critical surgeries. Sumatriptan and rocuronium will include Sagent’s proprietary PreventIV MeasuresT labeling and packaging, which can help clinicians differentiate these offerings from other products or dosages.” Sumatriptan and rocuronium will be the eighth and ninth products approved under the Sagent and Strides Arcolab partnership. Sagent and Strides Arcolab are jointly developing, supplying and marketing more than 25 injectable products for the U.S. market. Strides is responsible for developing and supplying injectable products which Sagent markets in the United States.

  

 

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