Regulatorische Updates

FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.

The FDA has approved ANDA 077351, covering a range of oral acid‑reducer and heartburn‑prevention products listed under various brand names.

SUN PHARM received FDA approval for ANDA077058 covering Pantoprazole Sodium delayed‑release tablets (20 mg and 40 mg). Multiple labeling supplements were approved between 2009 and 2015.

Il Dong Pharmaceutical Group, with the Korea Fair Trade Mediation Agency, delivered practical fair‑trade law training to all staff on May 8, aiming to strengthen self‑compliance culture and compliance management.

The FDA has approved several labeling supplement submissions for discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) under ANDA 076765.

The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.

The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.

Sun Pharm Industries received FDA approval for an ANDA (ANDA081029) covering oral quinidine sulfate tablets (100 mg). The product is listed as discontinued, with multiple supplemental approvals for manufacturing and labeling.

The FDA has granted approval for ANDA080445, covering multiple injectable strengths of meperidine hydrochloride manufactured by Hikma Pharmaceuticals USA.

The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.

Health Canada has issued a retail recall of JAMP Temozolomide 140 mg capsules (lot RLTS0225A) because the active ingredient temozolomide is out of specification.

FDA issued a Complete Response Letter for HLB’s ribociclib NDA, citing cGMP deficiencies at the Chinese Hengrui manufacturing site.