ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, a specialized developer and manufacturer of niche pharmaceutical products, received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nimodipine 30mg capsules.

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.

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).

Arthur S. Przybyl, president and chief executive officer of ANI Pharmaceuticals stated, “This represents ANI’s first ANDA approval with our partner Sofgen. We are excited to have achieved this milestone and look forward to a successful launch.”