Regulatorische Updates

Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.

Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.

FDA granted approval for ANDA214219 covering oral Triazolam tablets (0.125 mg and 0.25 mg) manufactured by Ingenus Pharmaceuticals, LLC.

FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.

FDA has approved ANDA213409 for two oral solution products of nimodipine from ALKEM Labs, with one product receiving prescription status and the other tentative approval.

The FDA has approved ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.

The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.

Baxter Corp. has issued an urgent correction for its Likorall™ ceiling‑mounted patient lift due to potential motor shaft breakage and reduced safety system performance, which may cause the lift strap to descend faster than expected.

Baxter Corp. alerts users of a potential motor shaft breakage and reduced safety system performance in Likorall™ ceiling lifts, which may cause straps to lower faster.

The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.

The FDA has approved Alembic Pharmaceuticals’ generic Nitrofurantoin capsules (ANDA211935) for oral prescription use in 25 mg, 50 mg, and 100 mg strengths.

The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.