法规动态

The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.

The FDA granted approval for Rising’s clindamycin phosphate injection products (6, 12, and 18 mg/mL) under application ANDA203048.

ICCA's J.06.01 and J.06.02 releases warn that auto‑charting of infusion data can produce incorrect intake, output and net body balance values for units using automatic charting settings.

The Korean Pharmacists Association staged its 352nd day relay protest in front of Cheong Wa Dae, urging swift government and parliamentary action on longstanding Han Yak Sa concerns.

FDA approved labeling for Jubilant Generics' oral itraconazole 100 mg capsule (ANDA203445); the product is listed as discontinued.

TipsoBoc (ivosidenib) from Korea Serb... has entered health‑insurance price negotiations for IDH1‑mutant locally advanced or metastatic cholangiocarcinoma after passing the benefits evaluation committee in July.

FDA has approved ANDA202711 for Zydus Pharms' prescription indomethacin 75 mg extended‑release oral capsule, with labeling supplements filed in 2017, 2019, 2021 and 2024.

FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.

Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.

FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.

FDA records multiple labeling submissions for Teva’s discontinued oral tablet combining amlodipine besylate, valsartan, and hydrochlorothiazide (ANDA 200435). All listed product variants are marked discontinued.

Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.