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FDA approves Akorn’s mycophenolate mofetil following Form 483 resolution Posted 07/04/2017

US-based generic pharmaceutical manufacturer, Akorn Inc has announced that its sterile manufacturing site in Decatur, Illinois, USA has received a No Action Indicated (NAI) status from the US Food and Drug Administration (FDA). This is following the sites re-inspection in December 2016.

A previous inspection of the Decatur site that took place in June 2016 reported a number of site issues. It was subsequently issued with a Form 483 by FDA. Among the problems noted were media fill line issues that should have led to a halt in production and general quality control issues related to media fill lines. In addition, inspectors reported that both foreign matter and cracked vials were found in a sublot of the antibiotic clindamycin. However, the cause of these issues was not investigated nor were other sublots checked.

On 28 February 2017, Akorn announced that it had received approval from FDA for its abbreviated new drug application (ANDA) for mycophenolate mofetil for Injection, USP, 500 mg/vial.  This was the first new product approval for a product made in the Decatur plant since its re-inspection.  Mycophenolate mofetil is an immunosuppressant [1] and Roche’s originator product with the brand name CellCept.

It is reported that Akorn has 90 ANDAs filed with FDA. Although not all of these are produced at the Decatur plant, Akorn CEO stated that its new NAI status should mean that more filings will be approved.

At the same time as this approval, it is reported that FDA also approved a new drug application (NDA) for ephedrine sulfate, an anaesthetic.

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1. GaBI Online - Generics and Biosimilars Initiative. Equivalence of generic immunosuppressants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Generics/Research/Equivalence-of-generic-immunosuppressants

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