FDA approves long-lasting OTC pain reliever combining acetaminophen and naproxen

Nasdaq sees best day in over a month as Microsoft breathes life back into AI trade By Jonathan Stempel NEW YORK, July 30 (Reuters) - A federal appeals court on Thursday revived portions of nationwide litigation in which consumers accused drugmakers such as Procter & Gamble and retailers such as CVS of selling billions of dollars of over-the-counter decongestants that didn’t work. The litigation comprised about 100 lawsuits filed after a U.S.

The FDA approved Kenvue’s over-the-counter “Tylenol with Naproxen,” combining 325 mg acetaminophen and 110 mg naproxen sodium per tablet. Kenvue says it starts working within 30 minutes and provides relief for up to 12 hours. The FDA granted three years of exclusivity. Candidate use is temporary relief of minor aches and pains in adults and children 12+.

Kimberly-Clark (KMB) plans to acquire Kenvue, Johnson & Johnson’s consumer health business, to expand its essential health portfolio. The article says the deal could shift KMB toward higher-margin consumer health categories. It cites KMB stock at $109.70, about 6% below an analyst target of $117.00, and notes weaker 1-, 3-, and 5-year returns.

Kenvue said the FDA approved TYLENOL with Naproxen, an OTC fixed-dose combo of 650 mg acetaminophen and 220 mg naproxen sodium. The company says it starts working in under 30 minutes and lasts up to 12 hours, supported by eight clinical studies showing better relief than either ingredient alone. FDA granted three years of exclusivity.

Kenvue (KVUE) said the FDA approved TYLENOL with Naproxen, an OTC fixed-dose combo of acetaminophen 650 mg and naproxen sodium 220 mg. The company cites eight clinical studies showing better pain relief than either ingredient alone, with onset under 30 minutes and up to 12 hours of relief. It received three years of exclusivity and will be sold at major U.S. retailers.

The U.S. FDA approved Kenvue’s over-the-counter fixed-dose pill combining Tylenol (325 mg) and naproxen sodium (110 mg) for up to 12 hours of pain relief for adults and children 12+. The approval follows FDA review amid pregnancy-autism scrutiny and related lawsuits. Kenvue is set to be acquired by Kimberly-Clark for over $40B, expected to close this year.