Regulatory Updates
Sep 25, 2026•1 min read
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.
Regulatory Updates
Sep 22, 2026•1 min read
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.
Regulatory Updates
Sep 15, 2026•1 min read
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.
Regulatory Updates
Aug 30, 2026•1 min read
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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