Entereg accepted for fast-track pilot program
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Adolor expects to complete submission of Entereg (alvimopan) for postoperative ileus in the first half of 2004. The firm recently announced FDA's acceptance of the non-opioid analgesic into its continuous marketing application (CMA) Pilot 1 program, which allows sponsors of fast-track products to submit NDAs in portions (1Pharmaceutical Approvals Monthly March 1, 2004, p. 4). The Exton, Pa.-based firm has so far submitted two "reviewable units": nonclinical pharmacology/toxicology (announced May 7) and chemistry, manufacturing & controls (announced June 1). GlaxoSmithKline will co-promote the product in the U.S. and take the lead on development for opioid-induced bowel dysfunction (2Pharmaceutical Approvals Monthly Oct. 1, 2003, p. 15)...
You may also be interested in...
GSK/Adolor Entereg Gets Standard Review For Ileus Despite Fast Track Status
GlaxoSmithKline/Adolor’s non-opioid analgesic Entereg did not receive a priority review as requested; Adolor announced a standard review for the postoperative ileus NDA Sept. 8.
HGS Lymphostat-B Is 1 Of 7 Agents Selected For FDA’s Pilot 2 CMA Program
FDA has selected Human Genome Sciences’ lupus biologic Lymphostat-B for the continuous marketing application (CMA) Pilot 2 program, HGS announced March 4.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.