Strides Arcolab gets US drug regulator???s nod for Sumatriptan Succinate injection
Drug maker Strides Arcolab has received the United States Food and Drug Administration???s (US FDA) nod for Sumatriptan Succinate injection 6 mg (base)/0.5 mL, a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype.
Sumatriptan Succinate injection is used for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. The drug will be offered as 6 mg (base)/0.5 mL, packaged in a single-use vial. Sumatriptan had sales of around $200 million in the US markets during 2009, of which the market for 6 mg (base)/0.5 mL vial injection was $16.2 million, as per IMS data.
Apart from this, the pharma major has also secured the approval for Rocuronium Bromide 10mg/ml-5ml and 10 ml multi dose vials, a nondepolarizing neuromuscular blocking agent, from the US FDA. It is used as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Rocuronium will be offered as 10mg/mL, packaged in 50mg/5mL and 100mg/10mL multi dose vials. According to IMS data, the total US market for the drug in 2009 approximated $59 million.
Following this nod, the drug maker has now received total twelve sterile approvals in the current calendar year.
Further, Sumatriptan and Rocuronium will be launched under the partnership between the company and Sagent Pharmaceuticals. Both drugs are expected to be unveiled in the near future.
Strides Arcolab, a global pharmaceutical company, develops and manufactures a wide range of IP-led niche pharmaceutical products with emphasis on sterile injectables.
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