Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA078547 for Nicotine Polacrilex OTC Chewing Gum
The FDA has approved ANDA078547 for a 2 mg nicotine polacrilex chewing gum, an over‑the‑counter nicotine replacement product marketed under several brand names.
Regulatory Updates
Sep 25, 2026•1 min read
Pharmacies urged to lead systematic monitoring of OTC drug safety
Experts highlight need for pharmacy-based pharmacovigilance for over‑the‑counter medicines due to hidden adverse events.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves Multiple Ibuprofen Oral Suspension Products (ANDA 210602)
The FDA's recent ANDA 210602 approval includes a range of ibuprofen oral suspension products, covering dye‑free, kosher, and flavored versions for OTC use.
Regulatory Updates
Sep 24, 2026•1 min read
Korean pharma firms detect illegal online sales of OTC medicines on e‑commerce site
Pharma companies in Korea have identified abnormal distribution of their OTC drugs on an online shopping mall that also sells supplements and masks, prompting a response to curb illegal sales.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Grants ANDA079044 Approval for Nicotine Polacrilex Chewing Gum (OTC)
The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA076667 for Fexofenadine HCl and Pseudoephedrine HCl OTC Tablet
The FDA approved ANDA076667 for an over‑the‑counter extended‑release oral tablet containing 60 mg fexofenadine HCl and 120 mg pseudoephedrine HCl, marketed by Dr. Reddy’s.
Regulatory Updates
Sep 23, 2026•1 min read
KPA Calls for Clear Licensing Rules for Pharmacists and Herbal Pharmacists in 358‑Day Relay Protest
The Korean Pharmaceutical Association held a relay protest at the Blue House, urging the government to clarify licensing scopes and set standards for herbal pharmacists' OTC sales and pharmacist employment.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA076568 for Nicotine Polacrilex OTC Chewing Gum
The FDA has approved ANDA076568 for Nicotine Polacrilex chewing gum, an over‑the‑counter nicotine replacement product available in 4 mg and 2 mg strengths.
Regulatory Updates
Sep 22, 2026•1 min read
Hanmi Pharm Secures Approval for Azelaic Acid Cream Amid Growing Korean Acne Market
Hanmi Pharm received approval for its 20% azelaic acid cream, AzelClean, as four new azelaic acid products enter a market that has more than tripled in size this year.
Regulatory Updates
Sep 19, 2026•1 min read
South Korea may delay convenience‑store OTC medicine expansion pending compliance review
The health ministry says expansion of safe OTC items in convenience stores could be postponed if illegal or improper sales practices are not corrected.
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 Lists Fexofenadine Hydrochloride Products Under ANDA076502
The FDA database shows multiple oral tablet products of Fexofenadine Hydrochloride under application ANDA076502, with strengths from 30 mg to 180 mg, some discontinued and others OTC.