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
UsernamePublicRestriction

Ivax Glucovance generic approved

Executive Summary

FDA approves Ivax' ANDA for generic version of Bristol-Myers Squibb's Glucovance (glyburide/metformin) with 180 days of marketing exclusivity Feb. 18. Ivax says it is building inventory for launch. Glucovance lost marketing exclusivity Jan. 31. Ivax is in the middle of 180-day exclusivity for metformin extended-release (Bristol's Glucophage XR) (1"The Pink Sheet" Dec. 1, 2003, p. 17)...

You may also be interested in...



Glucovance generics launch

Ivax launches its generic version of Bristol-Myers Squibb's Glucovance (glyburide/ metformin) May 4, triggering 180 days of marketing exclusivity. Par entered the market with an "authorized" generic the same day. Ivax has been building inventory since ANDA approval Feb. 18 (1"The Pink Sheet" Feb. 23, 2004, In Brief)...

Glucophage XR Settlement: Purepac, Ivax Split Generic Profits For 180 Days

Ivax and Purepac's exclusivity rights settlement for a generic version of Glucophage XR means FDA has avoided a legal challenge to its interpretation of first-to-file requirements for new ANDAs compared to amended applications

Coronavirus Update: Novavax Launches Phase III Trial In UK As Virus Surges Back

Novavax aims to recruit 10,000 subjects in the UK, and will include a flu vaccination co-administration for some participants.

UsernamePublicRestriction

Register

PS122308

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