ANI Pharmaceuticals and Sofgen Receive FDA Approval

ANI Pharmaceuticals Inc. said that its ANDA collaboration partner Sofgen has received approval from the U.S. Food and Drug Administration (FDA) 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.

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

Nimodipine is indicated 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).