Ranbaxy Consent Decree Includes Unusual Provisions On Exclusivity Relinquishment
By
Sue Sutter / Email the Author / “The Pink Sheet” Jan. 30, 2012, Vol. 74, No. 5
Regulatory Update / Word Count: 1825 / Article # 00120130016
Executive Summary
The company’s consent decree with FDA contains unusual language governing the relinquishment of marketing exclusivity for up to eight pending ANDAs. Since the products have not been publicly identified, it is unclear whether the provisions are punitive in nature, reflect technical defects with the applications or merely clarify a 2003 statutory requirement governing forfeiture.
Already a Subscriber?
Log in for complete access.
Log In
Questions?
Call Toll-Free (800) 332-2181 or +1 (908) 547-2159.