Regulatory Updates
Sep 21, 2026•1 min read
MFDS recalls 4 hand sanitizers after content non‑compliance in nationwide test
The Korean Food & Drug Administration tested 100 top‑selling hand sanitizers and found four failing the ingredient‑content standards, prompting sales suspension, recall and disposal.
Regulatory Updates
Sep 21, 2026•1 min read
Understanding Criminal Procedure and Evidence Admissibility in Korean Law
The article explains basic criminal procedure in Korea, noting that evidence obtained unlawfully is inadmissible and may prevent conviction without other proof.
Regulatory Updates
Sep 21, 2026•1 min read
Regulatory Shift Reduces Comparative Clinical Trials in Biosimilar Development
Large-scale comparative clinical efficacy studies are being scaled back, with global regulators emphasizing advanced quality analysis and PK data, according to a KoBIA report.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Sandoz ALPHAZINE (phendimetrazine) ANDA085034
The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 084553 for COMPOUND 65 Oral Capsule
FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Testosterone Injectable (Product 001) – Submission History
The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Over-the-Counter Famotidine ANDA077367 for Dr. Reddy's Labs
The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Sandoz OFLOXACIN Ophthalmic Solution (ANDA 076231)
The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Updates for Granisetron Injection (ANDA078564)
FDA has approved labeling supplements for ANDA078564, a discontinued Granisetron Hydrochloride injection product by Wockhardt USA, with submissions dated 2008, 2014, and 2015.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Trimethobenzamide Injection (ANDA 089094)
The FDA has listed the injectable Trimethobenzamide Hydrochloride (product 001) from sponsor SoloPak as discontinued under ANDA 089094.