Regulatorische Updates

The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.

The FDA has approved the ANDA for REVONTO, a 20 mg/vial injectable dantrolene sodium product from USWM, LLC, for prescription use.

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.

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.

The FDA has approved application ANDA076330 for octreotide acetate injectable products manufactured by Hikma Pharmaceuticals, available in two dosage strengths.

FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.

The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.