Sage Therapeutics now boasts the first-ever approval for a prescription drug for postpartum depression, thanks to the FDA’s Tuesday nod for Zulresso. But it also faces some big challenges in launching the new drug.

Regulators greenlighted the product—a one-time infusion bearing a list price of $34,000—after a three-month delay, which they took to give themselves extra time to work on a risk evaluation and mitigation strategies (REMS) program. The drug carries a black box warning—the FDA's most serious—for loss of consciousness events and extreme sedation.

But while REMS can often get in the way of uptake, Sage’s executives don’t think it’ll be a hurdle. “We can make it feasible for physicians and patients … to participate in the REMS,” chief business officer Mike Cloonan said, adding that “we’re confident in our ability to execute against” the safety-ensuring program.