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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