Mayne Pharma files NDA for E4/DRSP with FDA

16 April 2020

Australian drugmaker Mayne Pharma (ASX: MYX) closed trading today up 11.6% at A$0.385, after saying it has submitted a New Drug Application (NDA) to the US Food and Drug Administration, seeking marketing authorization for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy.

If approved by the FDA, E4/DRSP is expected to be made available to patients in the US market in the first half of calendar 2021.

Mayne acquired rights to the product last October from Belgium’s Mithra Pharmaceuticals (Euronext Brussels: MITRA), to commercialize its novel oral contraceptive Estelle, comprising estetrol (E4), and drospirenone, (E4/DRSP), in the USA, under a deal worth up to $295 million.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK