Nextstellis® Receives FDA Marketing Exclusivity And Phase III Data Published

27 May 2021, 07:30 CEST – Adelaide, Australia and Liege, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the novel oral contraceptive Estelle® – under the trademark Nextstellis® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) – has been granted marketing exclusivity as a new chemical entity (NCE) from the US Food and Drug Administration (FDA). The exclusivity runs for five years from FDA approval of the New Drug Application for Nextstellis.