Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ARTHROTEC (Diclofenac Sodium and Misoprostol)
The FDA has approved NDA020607 for ARTHROTEC, a prescription oral delayed‑release tablet combining diclofenac sodium with misoprostol in 50 mg/0.2 mg and 75 mg/0.2 mg strengths.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues TOLECTIN Oral Tolmetin Products (NDA017628)
The FDA has marked the oral Tolmetin tablets TOLECTIN 600 mg and TOLECTIN 200 mg as discontinued, with a record of multiple manufacturing and labeling submissions from 1979 to 1993.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Labeling Updates for Generic Levofloxacin Tablets (ANDA 076361)
The FDA has approved a series of labeling submissions for generic levofloxacin tablets (250 mg, 500 mg, 750 mg) under ANDA 076361, most recently on Sep 9 2024.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Multiple Clozapine Submissions; All Listed Tablet Products Discontinued
FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approval History for CYLERT (NDA 017703)
CYLERT, an oral chewable tablet with 37.5 mg PEMOLINE, is listed as discontinued. The FDA record shows a series of labeling, manufacturing and priority submissions from 1976 to 2005.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves VARUBI (rolapitant) Intravenous Emulsion under NDA 208399
VARUBI, an intravenous rolapitant hydrochloride emulsion by TERSERA, received FDA approval (NDA 208399) with original submission in 2017 and labeling updates in 2018 and 2020; marketing status is discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ACTHAR Injectable (NDA007504)
The FDA’s NDA007504 approval for ACTHAR injectable (25 UNITS/VIAL and 40 UNITS/VIAL) by Sanofi Aventis includes multiple priority labeling supplements, though the products are listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
MEPROBAMATE (ANDA 085721) Discontinued Oral Tablet – FDA
FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.
Regulatory Updates
Sep 10, 2026•1 min read
MFDS updates safety labeling for triptolide and azathioprine drugs
The Korean MFDS will amend approval labeling for triptolide and azathioprine products, adding severe skin reaction warnings for triptolide and PRES and tremor warnings for azathioprine.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANI PHARMS' Fosinopril/HCTZ Tablets (ANDA 076608)
The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.
Regulatory Updates
Sep 10, 2026•1 min read
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Regulatory Updates
Sep 9, 2026•1 min read
CAM-METRAZINE (ANDA085320) Discontinued Oral Tablet by Chartwell Rx
Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.