Will REMS Delay Generics? Dr. Reddy’s Revlimid Petition May Help Determine Answer
This article was originally published in PharmAsia News
Executive Summary
Dr. Reddy's is urging U.S. FDA to start now to define a policy that assures that restricted distribution programs and other types of Risk Evaluation and Mitigation Strategies won't be used to block generic drug approvals
You may also be interested in...
United And Divided: Natco's Patent Challenge On Revlimid Leads Dr. Reddy's To Up Its Pitch
MUMBAI - Natco Pharma's patent challenge earlier this month over Celgene's blockbuster multiple myeloma drug Revlimid (lenalidomide) has led India's Dr. Reddy's Labs to fast-track its own development of the product, which was brought under a restricted distribution plan by U.S. FDA due to its risky profile
United And Divided: Natco's Patent Challenge On Revlimid Leads Dr. Reddy's To Up Its Pitch
MUMBAI - Natco Pharma's patent challenge earlier this month over Celgene's blockbuster multiple myeloma drug Revlimid (lenalidomide) has led India's Dr. Reddy's Labs to fast-track its own development of the product, which was brought under a restricted distribution plan by U.S. FDA due to its risky profile
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