Regulatory Updates
Aug 30, 2026•1 min read
FDA approves labeling and manufacturing updates for ISOPAQUE 280 (NDA 017506)
The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves REVONTO (Dantrolene Sodium) Injectable – ANDA078378
The FDA has approved the ANDA for REVONTO, a 20 mg/vial injectable dantrolene sodium product from USWM, LLC, for prescription use.
Regulatory Updates
Aug 30, 2026•1 min read
Apotex Apo‑Semaglutide Injection Recall Due to Incorrect Dose Display
Apotex Inc. has recalled lot 700059A of its Apo‑Semaglutide 2 mg pen after the dose window may incorrectly show a 2 mg dose, delivering 2 mg instead of the intended 0.25 mg or 0.5 mg.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Lists ANDA083760 for Watson Labs' Pyridoxine Hydrochloride Injection (Discontinued)
The FDA database shows an ANDA (application ANDA083760) submitted by Watson Labs for a pyridoxine hydrochloride injectable (100 mg/mL) that is currently listed as discontinued.
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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Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA087274 for Hydroxyzine Injectable – Watson Labs
FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.