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Exxua: A Lengthy Approval Under a Regulatory Lens

Exxua: A Lengthy Approval Under a Regulatory Lens
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New yorkUnited statesClin psychopharmacolKaur gillMead johnsonBristol myers squibbFabre kramer phaemaceuticalsPsychopharmacologic drugs advisory committee meetingPsychopharmacologic drugs advisory committeeFabre kramer pharmaceuticals announcesEuropean medicines agencyFabre kramer pharmaceuticalsIntj health servDrug administrationBristol myers companyNew york times

Gepirone Offers New Option for Major Depressive Disorder

Gepirone does not induce sexual dysfunction, a common limitation associated with SSRIs.

Stanislaw mikulskiClin psychopharmacolKaur gillFabre kramer pharmaceuticalsFabre kramer pharmaceuticals announcesMajor depressive disorderHamilton depression rating scaleOnly oral selectiveReceptor agonist

Eleven Potentially Practice-Changing Drugs Were Approved by the FDA in 2023

These drugs have interesting mechanisms, unique use, or may support expanded indications in the future.

United statesTreasure islandVonoprazan voqueznaZuranolone zurzuvaeDaprodustat jesduvroqGepirone exuaaTarsus pharmaceuticalsNational library of medicineSaturni study groupCenters for diseaseNational centerBausch health companiesFabre kramer pharmaceuticals announcesPhathom pharmaceuticalsMission pharmacal companyFabre kramer pharmaceuticals inc

FDA Approves First Oral Selective 5HT1A Receptor Agonist for MDD

Following a long path to approval, gepirone hydrochloride extended-release tablets (Exxua) is the first FDA-approved medication with this novel mechanism of action for adults with MDD.

United statesAnitah claytonUrupong adobestockClin psychopharmacolStephen stahlKaur gillNonacsr gepironeFabre kramer pharmaceuticals announcesBipolar support allianceDrug administrationUniversity of californiaNeurobehavioral sciencesVirginia schoolPsychiatric times editorial boardChief executive officerKramer pharmaceuticals announces

Fabre-Kramer Pharmaceuticals Announces FDA Approval of EXXUAtm, the First and Only Oral Selective 5HT1a Receptor Agonist for the Treatment of Major Depressive Disorder in Adults

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S. Food and Drug Administration (FDA).

United statesAnitah claytonStephen kramerStephen stahlBipolar support allianceUniversity of virginia school medicineUniversity of californiaFabre kramer pharmaceuticals incNeuroscience education instituteDrug administrationFabre kramer pharmaceuticals announcesDepartment of psychiatry neurobehavioral sciencesPrnewswire fabre kramer pharmaceuticals incOnly oral selectiveReceptor agonistMajor depressive disorder

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