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Pepcid Not Withdrawn Due to Safety/Efficacy: FDA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Register notice: FDA determines that Valeant Pharmaceuticals Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for re...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).
Human Drugs
FDA Hits Drug Outsourcing Facility with 5-page 483
An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) results in a five-page Form FDA 483 that cited several GMP deficiencies.
Human Drugs
Pfizer Atopic Dermatitis Drug Approved
FDA approves a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating certain adults living with refractory, moderate-to-...
Medical Devices
Nextremity Foot Joint Device Cleared
FDA clears a Nextremity Solutions 510(k) for its InCore Subtalar System, indicated for reduction and internal fixation of arthrodeses, osteotomies, an...
