MSB to dispute FDA finding in Type A meeting, page-470

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6 October 2020, Adelaide Australia: Mayne Pharma Group Limited (ASX: MYX) has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for a generic version of NUVARING®.Mayne Pharma is working closely with its development partner, Mithra Pharmaceuticals, and the FDA to address the questions raised in the CRL. Following submission of the response to the CRL, Mayne Pharma will then receive a new target action date from the FDA.Mayne Pharma’s CEO Scott Richards said, “We are confident we can address the issues raised in the letter in a timely manner. Pleasingly, the FDA has indicated that Mayne Pharma and its development partner Mithra have an acceptable manufacturing process for generic NUVARING. Furthermore, the market opportunity continues to be highly attractive with only one independent generic approved and an addressable market of US$920m1.”