CDER approves sNDAs from Bayer for Zegerid OTC powder and private label manufacturer Dexcel Pharma for omeprazole delayed release tablets to add label warnings on drug-drug interactions for methotrexate and mycophenolate mofetil.

Unlike other OTC deals J&J made since McNeil Consumer Healthcare’s quality-control problems led to widespread recalls and a consent decree with FDA, the firm is not divesting the digestive health lines. Infirst will manufacture and market the products in the U.S. for an undisclosed period before the brands return to McNeil.

Avadim Health could get FTC scrutiny after it declines to comply with two findings by an industry self-regulation group to discontinue 26 claims for its Theraworx Relief homeopathic products. It says the analysis “misapplied the well-recognized standards of substantiation” established by FTC.