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BRIEF-FDA Removes Alcohol Ban With Addyi, Non-Hormonal Treatment For Hypoactive (Low) Sexual Desire Disorder (HSDD)

Published 2019-09-04, 08:18 a/m
© Reuters.  BRIEF-FDA Removes Alcohol Ban With Addyi, Non-Hormonal Treatment For Hypoactive (Low) Sexual Desire Disorder (HSDD)

Sept 4 (Reuters) - Sprout Pharmaceuticals:

* FDA REMOVES ALCOHOL BAN WITH ADDYI - THE FIRST-AND-ONLY NON-HORMONAL TREATMENT FOR HYPOACTIVE (LOW) SEXUAL DESIRE DISORDER (HSDD)

* SPROUT - FDA ALSO REMOVED REQUIREMENT UNDER ITS REMS PROGRAM FOR HEALTHCARE PRACTITIONERS OR PHARMACIES TO BE CERTIFIED TO PRESCRIBE OR DISPENSE ADDYI

* SPROUT - TO MAKE ALL LABELING ELEMENTS CONSISTENT WITH FDA'S FINDINGS, BOXED WARNING WILL CHANGE

* SPROUT - FDA STATED THAT PATIENTS SHOULD DISCONTINUE DRINKING ALCOHOL AT LEAST TWO HOURS BEFORE TAKING ADDYI

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