Regulatorische Updates

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.

Experts highlight need for pharmacy-based pharmacovigilance for over‑the‑counter medicines due to hidden adverse events.

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.

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.

The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.

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.

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.

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.

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.

The health ministry says expansion of safe OTC items in convenience stores could be postponed if illegal or improper sales practices are not corrected.

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.

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.