OTC Drugs

MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.

FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.

The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.