Regulatory Updates
Sep 11, 2026•1 min read
FDA approves KAZANO alogliptin/metformin tablets (NDA 203414)
The FDA has approved the prescription oral tablet KAZANO, containing alogliptin benzoate and metformin hydrochloride, under NDA 203414.
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 10, 2026•1 min read
FDA Approves LEUCOVORIN CALCIUM (ANDA207241)
The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)
FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues Oral Solution PAMELOR (Nortriptyline Hydrochloride) – NDA 018012
The FDA records show PAMELOR oral solution (nortriptyline hydrochloride) is discontinued, with a history of labeling and manufacturing submissions from 1977 to 2014.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Sorbitol-Mannitol (NDA018316) for Urethral Irrigation
The FDA has approved the prescription drug Sorbitol-Mannitol (NDA018316), a urethral irrigation solution containing mannitol and sorbitol, manufactured by ICU Medical Inc.
Regulatory Updates
Sep 6, 2026•1 min read
Korea's Central Pharmaceutical Review Committee Conditions Approval of Handok's Myelofibrosis Drug for Low Platelet Patients
The committee deemed patients with platelet counts below 50,000/μl an unmet clinical need and granted conditional approval of Handok's Bonjo capsule, pending confirmatory trial data.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves NDA007392 for Secobarbital Sodium Injection (Seconal)
FDA has approved NDA007392 for Seconal Sodium injectable, a secobarbital sodium product by Lilly, with a detailed submission history and discontinued marketing status.
2
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Sorbitol 3% Irrigation Solution (NDA017863)
The FDA granted approval for Baxter Healthcare's prescription Sorbitol 3% irrigation solution (NDA017863), a human drug administered via irrigation.
1
Regulatory Updates
Sep 4, 2026•1 min read
Dongguk Pharmaceutical's Rosutanmet Tablets Lose Health Insurance Coverage After Approval Cancellation
Two Dongguk Pharmaceutical Rosutanmet tablet products (500/5 mg and 500/10 mg) will have health‑insurance reimbursement stopped from the 28th after the Daejeon regional authority cancelled their approvals.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Records Show Discontinued AMINOPHYLLIN Tablet Products and Historical Submissions
The FDA database lists two discontinued oral tablet products named AMINOPHYLLIN (100 mg and 200 mg) and documents multiple labeling and manufacturing submissions approved between 1977 and 1991.
Regulatory Updates
Sep 1, 2026•1 min read
Korea Novo Nordisk Pharma’s Alhemo Prefilled Pen Gains MFDS Approval for Hemophilia A & B Prophylaxis
Alhemo® prefilled pen (consiliumab) received MFDS approval for routine prophylaxis in patients 12 years and older with hemophilia A or B, offering a new treatment option in South Korea.