FDA Related News

Human Drugs

Injectable Cetirizine Approved for Acute Urticaria

FDA approves a TerSera Therapeutics NDA for Quzyttir (cetirizine hydrochloride) injection for treating acute urticaria in adults and children.

Human Drugs

Safety Alert on Efficient Labs Cough Syrups

FDA issues a safety alert on Efficient Laboratories Rompe Pecho EX and Rompe Pecho CF cough syrups due to microbial contamination risks.

Federal Register

Info Collection Extension on Tobacco Form

Federal Register notice: FDA seeks comments on an information collection extension entitled Potential Tobacco Product Violations Reporting Form.

Human Drugs

Mortality Concerns Cloud Shionogis Cefiderocol: FDA

FDA drug reviewers raise mortality concerns with a Shionogi urinary infection NDA for cefiderocol injection that heads to an advisory committee vote.

Medical Devices

Subtle Medical Imaging Software Cleared

FDA clears a Subtle Medical 510(k) to market SubtleMR, an artificial intelligence image processing software.

Human Drugs

Novens Schizophrenia Transdermal Patch Approved

FDA approves a Noven Pharmaceuticals NDA for Secuado (asenapine) transdermal system for treating adults with schizophrenia.

FDA Pushed to Release Company Application Data

NPR reports that transparency advocates are pushing FDA to release to the public more data from drug and medical device applications.

Human Drugs

CGMP Violations at Indias Torrent Pharmaceuticals

FDA warns Indias Torrent Pharmaceuticals about CGMP violations in its production of finished pharmaceuticals.

Human Drugs

Glenmark Pharmaceuticals CGMP Violations

FDA warns Indias Glenmark Pharmaceuticals about a CGMP violation in its production of finished pharmaceuticals.

Human Drugs

Inactive Ingredient Database Suggestions

Three stakeholders suggest changes to an FDA draft guidance on the inactive ingredient database.