FDA Clears Kenvue's TYLENOL With Naproxen, First OTC Fixed-Dose Combination
(RTTNews) - Kenvue Inc. (KVUE) announced that the FDA has approved TYLENOL with Naproxen, the first and only over the counter fixed dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg) for pain relief.
This new formulation combines the fast-acting relief of acetaminophen with the long-lasting anti-inflammatory effect of naproxen sodium, beginning to work in under 30 minutes and providing up to 12 hours of relief in a single dose. The approval addresses a critical gap in pain management, as surveys show that three out of four persistent pain sufferers are dissatisfied with current options.
The FDA decision is supported by eight clinical studies demonstrating superior pain relief compared to acetaminophen or naproxen sodium alone. TYLENOL with Naproxen has been granted three years of exclusivity, underscoring its significance in expanding non-opioid pain relief choices.
Company executives emphasized that the product simplifies pain management by eliminating the need to coordinate multiple medications.
Dr. Rajesh Mishra, Chief Medical Officer, Kenvue, noted that the combination offers "fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose."
TYLENOL with Naproxen will be available soon at major U.S. retailers nationwide. KVUE has traded between $14.02 and $22.87 over the past year. The stock closed Friday's trading at $19.28, up 2.01%.
