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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#Octreotide ×

UPDATED
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products
FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.
UPDATED
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
FDA Approves Fresenius Kabi’s OCTREOTIDE Acetate Injectable (ANDA 077457)
The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.
UPDATED
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
FDA Approves ANDA076330 for Octreotide Acetate Injection
The FDA has approved application ANDA076330 for octreotide acetate injectable products manufactured by Hikma Pharmaceuticals, available in two dosage strengths.
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