ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nimodipine 30mg capsules. ANI and Sofgen expect to begin shipping to customers this year.
Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid haemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e. Hunt and Hess Grades I-V).
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