FDA Approves First Fixed-Dose Acetaminophen-Naproxen Combination for Over-the-Counter Pain Relief

The U.S. Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) fixed-dose combination of acetaminophen 650 mg and naproxen sodium 220 mg (Tylenol with naproxen, Kenvue). This new formulation is designed to provide pain relief for 12 hours with an onset of action in less than 30 minutes. The FDA granted a three-year period of exclusivity for this new OTC formulation.