Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Agile SEC filing reveals FDA rejection for Twirla contraceptive

This article was originally published in Scrip

Executive Summary

Hidden deep inside a 17 March S-1 filing with the Securities and Exchange Commission (SEC) was the disclosure from Agile Therapeutics it had received a complete response letter (CRL) from the FDA for the firm's experimental once-weekly, low-dose contraceptive patch Twirla (AG200-15).

You may also be interested in...



Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte.

Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.

Keeping Track: Resubmissions For Tlando And Twirla NDAs, And A BTD For Pomalyst

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track: So. Much. News.

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Related Companies

UsernamePublicRestriction

Register

PS100968

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel