Actualizaciones regulatorias

The FDA has approved an Abbreviated New Drug Application (ANDA077826) for fenoldopam mesylate injection submitted by Teva Parenteral.

FDA has approved Teva Pharmaceuticals' ANDA077528 for an oral capsule combining olanzapine and fluoxetine, with several dosage strengths, as of Feb 26 2021.

The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.

A Democratic Party MP proposes amending the Medical Aid, National Health Insurance and Inheritance Tax laws to subsidize caregiving expenses and allow deductions from inherited estates.

The Seongnam Pharmacists Association completed its 2026 training program at Seoul National University Hospital, covering six credits and addressing online drug delivery concerns.

Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.

Health Canada alerts that counterfeit laser hair removal devices marketed as “Soprano” are being sold to clinics in Canada, posing health risks and violating regulations.

The Korean Medical Association calls for a fiscally sustainable 2027 health insurance premium rate as the 15th Health Insurance Policy Review Committee meets on the 8th.

The Ministry of Food and Drug Safety announced several staff transfers and promotions on Sep 4 and Sep 7, 2026, covering food safety, consumer protection and bio‑pharmaceutical divisions.

The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.

FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.

The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.