Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.
The US Food and Drug Administration’s request for additional information from the sponsor of a proposal for the country’s first OTC daily oral contraceptive wasn’t unusual as a part of the agency’s evaluation of new drug applications.
However, whether the FDA’s handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel, a progestin-only formulation branded Opill, continues...
Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.
Navamedic adds Ventizolve to its portfolio shortly after Norway switched the opioid overdose reversal drug from Rx to OTC.
Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.
Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.
“Women’s health continues to be ignored, underfunded, and sidelined. Too many women still die from preventable causes or live in poor health. That must change,” says Bill Gates.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
A round up of the latest moves in Europe's consumer health market: Enzymatica appoints CEO; Haleon hires DACH marketing chief; Futura confirms interim CEO.
