Mayne Pharma Group to Respond to US FDA Letter Within Prescribed Timeframe

MT Newswires Live

2025/05/14

Mayne Pharma Group (ASX:MYX) said it takes the views of the US Food and Drug Administration seriously and it will respond to an untitled letter sent by the regulator within the prescribed timeframe, according to a Wednesday Australian bourse filing.

It received an untitled letter from the US FDA Office of Prescription Drug Promotion on April 28, related to certain promotional claims used in a speaker presentation for NEXTSTELLIS, a combined oral contraceptive.

It said it voluntarily withdrew the speaker presentation referenced in the letter. The matter is not expected to impact the firm's ability to continue to sell and distribute NEXTSTELLIS in the US.

Its shares fell 13% on market close on Wednesday.

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