Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves Manufacturing Supplements for LIORESAL (baclofen) Tablets
The FDA has approved a series of priority manufacturing (CMC) supplement submissions for the discontinued LIORESAL baclofen tablets (10 mg and 20 mg).
Regulatory Updates
Sep 27, 2026•1 min read
OCUCLEAR Ophthalmic Solution (0.025% OxyMetazoline HCl) Discontinued
OCUCLEAR ophthalmic drops containing 0.025% oxyMetazoline hydrochloride have been discontinued; FDA records show a series of approved manufacturing and labeling submissions from 1986 to 2001.
Regulatory Updates
Sep 27, 2026•1 min read
Mallinckrodt Inc. Original ANDA 078273 Approved by FDA
Mallinckrodt Inc. received FDA approval for its original Abbreviated New Drug Application (ANDA) 078273 on September 19, 2007.
Regulatory Updates
Sep 24, 2026•1 min read
FDA approves PHOTOFRIN (Porfimer Sodium) injection – NDA020451
FDA granted approval for PHOTOFRIN, a porfimer sodium injectable marketed by Pinnacle Biologics, under application NDA020451.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Braintree Labs' PIZENSY Oral Lactitol Solution (NDA 211281)
FDA granted approval for NDA 211281, covering Braintree Labs' PIZENSY oral lactitol solution, with original approval in Feb 2020 and a labeling supplement in Aug 2021.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves GLOPERBA Oral Colchicine Solution (NDA 210942)
Scilex Pharmaceuticals' GLOPERBA, an oral colchicine solution (0.6 mg/5 mL), received FDA approval under NDA 210942, with supplemental updates in 2021 and 2024.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Nitrogen Inhalation Drug (NDA212315) for Prescription Use
The FDA has approved the prescription inhalation product NITROGEN, NF (NDA212315), a medical gas for respiratory use, sponsored by Universal Industrial Gases, Inc.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Glycine 1.5% Irrigation Solution (NDA 017633)
FDA records show multiple manufacturing and labeling approvals for Glycine 1.5% irrigation solution (NDA 017633); the product is now discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approval History for Discontinued Ophthalmic Product Naphazoline Hydrochloride
The FDA records show original approval in 1974 and multiple supplemental approvals for the ophthalmic solution Naphazoline Hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Submissions for Discontinued Ophthalmic Product Isopto Cetamide
FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.
Regulatory Updates
Sep 22, 2026•2 min read
EMA CHMP recommends 12 new medicines and multiple extensions in September 2026 meeting
The EMA Committee on Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and issued several biosimilar, generic, re‑examination and indication‑extension updates.
Regulatory Updates
Sep 21, 2026•1 min read
Korean Biochem Pharm Secures Approval for Silodosin‑Rosuvastatin Combination Tablets
Korean Biochem Pharm received regulatory approval for two silodosin‑rosuvastatin sustained‑release tablets, expanding Korean United Pharm’s product line.