Latest Federal Register Notices
FDA Withdraws NDA Approval of Bayer’s Baycol
Federal Register notice: FDA announces that at the company’s request it is withdrawing the approval of a Bayer NDA for Baycol (cerivastatin sodium) tablets. 08/17/2017
Wyeth’s Cordarone Not Withdrawn Due to Safety/Effectiveness
Federal Register notice: FDA determines that Wyeth Pharmaceuticals’ Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. 08/16/2017
Joint Advisory Committee to Review Purdue Opioid Pain Drug
Federal Register notice: A 9/14 joint advisory committee plans to review a Purdue Pharma supplemental NDA new for Butrans (buprenorphine) transdermal system for use in pediatric patients. 08/16/2017
Biomass Denominator Method to Help Antimicrobial Calculations
Federal Register notice: FDA seeks comments on a proposed method for applying a food animal biomass denominator to annual data on antimicrobials sold and distributed for use in food animals in the U.S. 08/15/2017
Comments Sought Scheduling Impact on 17 Drugs
Federal Register notice: FDA requests comments about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. 08/14/2017