OTC Drugs

NutriFusion adds development, innovation head; Dymatize adds tennis pro, Olympic medalist Tommy Paul to Squad; Icy Hot sponsors Unrivaled women’s hoops league; WNBA’s Stevens, Evans invest in, promote Mela Vitamins.

“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.

Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.

Volleyball great Gabby Reece promotes Stemregen Sport; eye care pharma Harrow changes scientific lead; sisters partner to launch Renew-V vaginal moisturizer; Haleon tabs former Unilever executive as chief customer officer; and former Bayer executive leads Perrigo’s expanded scientific office.

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.