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

U.S. FDA To Review Mylan's Application For Generic Copaxone; India Partner Natco Expects To Cross More Hurdles

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - Oncology drug maker Natco and its partner Mylan moved a step closer to a possible launch of a generic version of Teva's blockbuster multiple sclerosis drug Copaxone (glatiramer) after U.S. FDA accepted Natco's application for review

You may also be interested in...



India's Natco Eyes Generic For Celgene's Mega Brand Revlimid; Will REMS Scuttle The Move?

MUMBAI - Although U.S.-headquartered Celgene succeeded last year in preventing India's Dr. Reddy's Labs from conducting bioequivalence studies on its fast-growing multiple myeloma drug Revlimid (lenalidomide) - due to risk management and restricted distribution issues - it may have a much harder fight on its hands now

India's Natco Eyes Generic For Celgene's Mega Brand Revlimid; Will REMS Scuttle The Move?

MUMBAI - Although U.S.-headquartered Celgene succeeded last year in preventing India's Dr. Reddy's Labs from conducting bioequivalence studies on its fast-growing multiple myeloma drug Revlimid (lenalidomide) - due to risk management and restricted distribution issues - it may have a much harder fight on its hands now

Indian Government Denies Patent Application For Copaxone; Natco Pharma Says Obstacles Removed For Supply Of Generic Version Worldwide

MUMBAI - In a decision that could trigger a bigger battle, the Indian Patent Office has denied a patent application filed by an Israeli company for Copaxone(glatiramer), an innovative drug used in the treatment of multiple sclerosis

Related Content

UsernamePublicRestriction

Register

SC072761

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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