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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#Hikma Pharmaceuticals ×

UPDATED
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
FDA Approves Lorazepam Injectable (ATIVAN) NDA018140
The FDA granted approval for NDA018140, authorizing Lorazepam injectable (brand name ATIVAN) from Hikma Pharmaceuticals USA and Civica, Inc.
UPDATED
Regulatorische Updates
22. Sept. 2026•1 Min. Lesezeit
FDA Approves Buprenorphine ANDA078633 Sublingual Tablets
FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.
UPDATED
Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
FDA Approves Hikma Phenytoin Sodium Injection (ANDA 084307)
FDA has approved ANDA 084307 for Hikma Pharmaceuticals' generic phenytoin sodium injectable, available for intramuscular and intravenous use with multiple NDC listings.
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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