Sun Pharmaceutical Industries Ltd has announced that the USFDA has granted approval for its subsidiary for its Abbreviated New Drug Application (ANDA) to market a generic version of Sumatriptan Succinate injection, 6 mg (base)/0.5ml.
According to the company, this is the first ANDA approval for a Sumatriptan AutoInjector. Annual sale for Sumatriptan Succinate injections in the US is approximately $190 million.
Sumatriptan Succinate injection is indicated for the acute treatment of migraine attacks with or without aura and acute treatment of cluster headache episodes.