FDA approves nimodipine for subarachnoid haemorrhage- ANI Pharma/Sofgen
ANI Pharmaceuticals announced that it and Sofgen has received approval from the FDA of the Abbreviated New Drug Application (ANDA) for Nimodipine 30mg Capsules for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e. Hunt and Hess Grades I-V).
Comment: Trailing twelve-month sales for the product are $25 million, according to IMS Health, with two current competitors. ANI and Sofgen expect to begin shipping to customers this year.
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