규제 업데이트

The FDA approved application ANDA076605 for Ranbaxy’s oral gabapentin tablets (600 mg and 800 mg). Both products are currently listed as discontinued.

FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.

The FDA granted approval (AP) for ANDA 076672, an oral gabapentin solution 250 mg/5 ml submitted by TARO. The product is listed as discontinued.

FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.

The UK Medicines and Healthcare products Regulatory Agency has re‑examined safety warnings on gabapentin, pregabalin, benzodiazepines and Z‑drugs, with findings published in a Public Assessment Report.