Pink Sheet 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

Pretomanid Approval For Resistant TB: With Regulatory Flexibility Comes Usage Restrictions

Executive Summary

US FDA's approval of the TB Alliance's pretomanid regimen for highly treatment-resistant tuberculosis comes with an LPAD designation and advisory committee-requested language to limit use.

You may also be interested in...



US FDA Clarifies Populations And Anti-Infective Indications Eligible For Approval Under LPAD

Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.

Antifungal Drug Sponsors Seek Clearer Regulatory Pathway, Less Burdensome Trials

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

Hope For Price Flexibility After India Pretomanid Go-Ahead

Mylan gets approval in India for pretomanid as part of a combination regimen with bedaquiline and linezolid, providing new hope to patients with drug-resistant tuberculosis. Volume changes may provide opportunities to tweak prices.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS140692

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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