Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA216216 for METOLAZONE Tablets
The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)
The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves STEGLATRO (ertugliflozin) under NDA209803
The FDA approved STEGLATRO, an oral ertugliflozin tablet (5 mg and 15 mg) from Merck Sharp & Dohme, NDA209803.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA076589 for FLUMAZENIL Injectable Products
FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution
The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.
Regulatory Updates
Aug 27, 2026•1 min read
Unicycive Optimistic Third-Party Facility Can Meet FDA Standards, Says CEO
Unicycive is optimistic its third‑party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.
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Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves Multiple Submissions for APRESAZIDE (ANDA 084735)
The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA078965 for Norethindrone/Ethinyl Estradiol/Ferrous Fumarate Tablet
The FDA has approved ANDA078965 for a prescription oral tablet combining norethindrone, ethinyl estradiol, and ferrous fumarate, submitted by BARR.
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
PMDA Publishes Updated List of Approved Medical Devices (Apr 2004‑Sep 2025)
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted an updated list of approved medical devices covering April 2004 to September 2025.