FDA approves major depressive drug after rejecting it multiple times in past two decades
The FDA approved a Houston drugmaker’s tablet for adults with major depressive disorder last week, capping a decades-long back-and-forth between multiple companies and the regulator over questions of efficacy.
On Thursday, the privately held Fabre-Kramer Pharmaceuticals disclosed the FDA’s Sept. 22 greenlight. Exxua, known investigationally as gepirone, will become available “in pharmacies in early 2024.” The FDA had originally set a decision deadline of June 23.
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