Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves KVK TECH Betaxolol Hydrochloride Oral Tablets (ANDA078962)
The FDA has approved ANDA 078962 for Betaxolol Hydrochloride oral tablets, 10 mg and 20 mg, manufactured by KVK TECH. Both products are prescription‑only.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling Updates for Chartwell Rx’s Discontinued Desloratadine Tablet (ANDA078364)
The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
PMDA Requests Public Comments on Draft Regulatory Science Standards
The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.
Regulatory Updates
Sep 8, 2026•1 min read
PMDA Invites Public Comments on Draft Regulatory Science Standards
The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA083022 for DODEX Injectable (Cyanocobalamin)
The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.
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Regulatory Updates
Sep 7, 2026•1 min read
Four Experts Appointed as Direct Advisors to Korean National Assembly Speaker, Including Former MFDS Chief
The Korean National Assembly Speaker appointed four advisors—former MFDS head Jeong Seung among them—to guide policy on innovation growth, finance, future growth, and culture.
Regulatory Updates
Sep 5, 2026•1 min read
Telemedicine Institutionalization Shifts Focus to Prescription, Dispensing, and Drug Delivery in Korea
As telemedicine becomes formalized, discussions are moving toward prescription, dispensing, and medication delivery, highlighting public safety and regulatory challenges.
Regulatory Updates
Sep 5, 2026•1 min read
MFDS to Conduct Targeted Inspections of Customized Health Functional Food Sellers Aug 24-28
The Korean Ministry of Food and Drug Safety will inspect customized health functional food vendors from Aug 24-28, conducting guidance, sampling and testing to ensure product safety and quality.
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.
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Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA078292 for Dronabinol Oral Capsules (Discontinued)
FDA has approved ANDA078292 submitted by Rhodes for oral dronabinol capsules in 10 mg, 5 mg, and 2.5 mg strengths; all products are listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 077395 for Paroxetine Hydrochloride Oral Suspension (Discontinued)
The FDA approved ANDA 077395 for an oral suspension of Paroxetine Hydrochloride; the product is listed as discontinued and has a series of labeling supplement approvals.
Regulatory Updates
Sep 5, 2026•1 min read
MFDS Updates Labels for Inhaled Triple Therapy and Caspofungin Amid Post‑Marketing Findings
Korea's MFDS adds new safety precautions to a beclomethasone‑formoterol‑glycopyrrolate inhaler and revises caspofungin labeling regarding CRRT‑related drug adsorption.