Human Drugs
FDA Rejects Levo Therapeutics Carbetocin NDA
FDA issues Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and...
Human Drugs
FDA Extends Review on 2 bluebird Gene Therapies
FDA extends by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies betibeglogene autotemc...
Medical Devices
Device User Fee Negotiations at Standstill
FDA and the medical device industry are at a standstill in their negotiations on the next five-year iteration of the medical device user fee agreement...
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/30/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/14/2022.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 1/14/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Glenmark Seasonal Allergy Spray Approved
FDA approves a Glenmark Specialty NDA for Ryaltris (olopatadine HCl and mometasone furoate) a fixed-dose (metered) nasal spray for treating seasonal a...
Federal Register
Pepcid Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Valeant Pharmaceuticals Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for re...
Federal Register
Class 2 for OTC Electrocardiograph Software
Federal Register notice: FDA classifies electrocardiograph software for over-the-counter use into medical device Class 2 (special controls).
