FDA Actions in Brief October 2012

Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. Pfizer is now conducting a pharmacokinetic study for a once-daily formulation.

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.

Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.

The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.

Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.