FDA Approves First Over-the-Counter Tylenol and Naproxen Pain Pill, Awarding Kenvue Three-Year Exclusivity
The FDA has approved a nonprescription pill combining acetaminophen with the nonsteroidal anti-inflammatory drug naproxen, giving consumers a single-dose pain reliever designed to provide relief for up to 12 hours.
According to Kenvue, eight clinical trials showed the fixed-dose formulation, which contains 650 milligrams of acetaminophen and 220 milligrams of naproxen, begins working in under 30 minutes. The approval grants the company three years of marketing exclusivity for the new product.
From the sources (3 posts)
@wallstengineFDA approves the first OTC Tylenol-naproxen combination. Each dose contains 650 mg of acetaminophen and 220 mg of naproxen. Kenvue $KVUE says eight studies showed it starts working in under 30 minutes and lasts 12 hours. The new formulati
@reutersThe FDA approved a nonprescription, fixed-dose pill that combines Tylenol with the nonsteroidal anti-inflammatory drug naproxen for up to 12 hours of pain relief
@reutersUS FDA approves over-the-counter Tylenol combination pill for pain relief