Scrip is part of the Business Intelligence Division 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

Merck seeks FDA nod for hep C combo grazoprevir/elbasvir

This article was originally published in Scrip

Executive Summary

After some back-and-forth with the FDA over the status of the breakthrough therapy designation of Merck's experimental hepatitis C virus (HCV) combination drug grazoprevir/elbasvir (100mg/50mg) – which was eventually tweaked – the company is now seeking approval of the product in the US, announcing after the markets closed on 28 May it had submitted a new drug application (NDA).

Advertisement

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC028867

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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