Regulatorische Updates

A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.

FDA lists the oral Isoniazid 100 mg tablet from sponsor PERRIGO (ANDA083060) as discontinued, with no reference drug status.

The FDA has approved an ANDA for ACETAZOLAMIDE 250 mg oral tablets, with original and multiple supplemental approvals for labeling and manufacturing from 1978 to 2016.

FDA has approved ANDA076885 for Rabeprazole Sodium oral delayed‑release tablets (20 mg) sponsored by Pharmobedient, with multiple labeling submissions approved between 2013 and 2023.

FDA granted approval for ANDA078671 covering prescription NABUMETONE tablets (500 mg and 750 mg) from sponsor Invagen Pharms, manufactured by Exelan Pharmaceuticals and Cipla USA.

The FDA approved ANDA080094 for the oral tablet TRIPLE SULFOID, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, though the product is listed as discontinued.

The MHRA released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The MHRA released a summary of letters and notifications sent to healthcare professionals in August 2024 regarding medicines and medical devices.

MHRA released a summary of recent letters and notifications to healthcare professionals concerning medicines and medical devices for September 2024.

The FDA approved generic ciprofloxacin hydrochloride tablets (250 mg, 500 mg, 750 mg) under ANDA 076593, sponsored by Aiping Pharm and manufactured by Westminster Pharmaceuticals.

Health Canada permits temporary import and sale of South Korean‑authorized BONKY Calcitriol Injection 1 mcg/mL to mitigate a national shortage, highlighting labeling and pack‑size differences.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 17‑21 August 2026.