Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
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Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)
The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Daewoong Pharmaceutical Initiates Phase 1 Trials of Olmesartan‑Indapamide Triple Antihypertensive
Daewoong Pharma received MFDS approval for two Phase 1 studies of its olmesartan‑amlodipine‑indapamide combo (DWJ1622), assessing PK and safety in fasting (44) and fed (36) healthy adults.