In gestation: New OTC reproductive health products

The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.

Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.

The drug is also approved to treat schizophrenia and bipolar depression.

“Emrosi has potential to become the best-in-class oral medication to treat the condition,” said the CEO of Journey Medical.

The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.

Check out these important FDA updates from the month of October 2024.