This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness.
The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.
The U.S. health regulator’s reviewers on Friday raised concerns around allowing Perrigo Co’s birth control drug over the counter, saying switching to non-prescription sale could lead to inappropriate usage by consumers.
The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide.
Haleon believes it is not liable for any claims that may arise from U.S. litigation over the heartburn drug Zantac, the London-listed company’s CEO Brian McNamara told Reuters on Tuesday.
Perrigo Co. Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.
The proposed rule is intended to increase options for the development of safe and effective nonprescription drugs, according to the agency.
Pfizer plans to sell its 32% stake in Haleon, its consumer health venture with British drugmaker GSK, after the business lists as an independent company in July, GSK said on Wednesday.
The U.S. health regulator put on hold a trial designed to evaluate switching the prescription-only erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment, French drugmaker Sanofi said on Monday.