There is no active application for the product registration of zuranolone—the first and only oral treatment for postpartum depression (PPD)—in the Philippines, the Food and Drug Administration (FDA) said on Tuesday, Aug. 8.

"Currently, there is no ongoing application for product registration of Zuranolone with the FDA Philippines thru the Center for Drug Regulation and Research (CDRR). Likewise, no noted clinical trial protocol of the said product for postpartum treatment has been submitted to this Agency, to date," the agency stated.

FDA also mentioned that there is no application for a compassionate special permit for this medication from the CDRR.

This statement came after the U.S. FDA approved the use of zuranolone, or zurzuva, for adult PPD patients on Aug. 4.

"Should the Marketing Authorization Holder (MAH) of Zuranolone (Zurzuvae™) submits the necessary documents for application for product registration, it will undergo the usual evaluation process prior to approval," FDA noted.

Postpartum depression is a "serious and potentially life-threatening" condition in which women experience sadness, worthlessness, guilt, and, in severe cases, thoughts of harming themselves or their children.

An expert from the U.S. FDA’s Center for Drug Evaluation and Research emphasized that this condition can disrupt the maternal-infant bond between mothers and their offspring, potentially compromising their physical and emotional development.

Prior to this approval, the only accepted treatment for PPD was an intravenous injection administered by a licensed healthcare worker in a professional healthcare facility.