FDA Related News

Human Drugs

ViiV sNDA for Dovato as a Switch Treatment

ViiV Healthcare submits a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection.

Medical Devices

Improving Dental Device 510(k) Submissions

A CDRH Webinar discusses issues seen in dental device 510(k) submissions and ways in which they can be improved.

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.