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FDA Accepts ANI’s Refiled Cortophin Gel

For Indications Including Multiple Sclerosis, Rheumatoid Arthritis And Nephrotic Syndrome

 
• By Akriti Seth

ANI Pharmaceuticals has announced that the refiled sNDA for its Cortrophin Gel has been accepted by the FDA with a target action date of 29 October 2021. The company said that it was continuing to strengthen its rare disease business leadership team and overall organization to drive the Cortrophin Gel launch preparation.

Approval
After refusing the application last year, the FDA has accepted ANI’s refiled Cortophin Gel sNDA • Source: Alamy

ANI Pharmaceuticals, Inc. has announced that its supplemental new drug application for purified Cortrophin Gel (corticotropin) has been accepted by the US Food and Drug Administration for review, with a target action date of 29 October 2021.

“We look forward to further productive engagement with the FDA, and in parallel, we are focused on preparations for the launch of

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