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January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
29 Aug 2025 20:22 GMT
Addyi (flibanserin)
Drug hypersensitivity
The "Contraindications", … based on available information.
A FDA Drug Safety Communication was issued on … Counseling Information", and "Medication Guide" sections of the …
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FDA updates in urology: July 2025
02 Aug 2025 02:48 GMT
… FDA and European Medicines Agency authorization for a confirmatory phase 3 trial … , 2025, Sprout Pharmaceuticals announced FDA priority review of … an expanded indication of flibanserin (Addyi) to … trials are supporting expanded use of the non-hormonal treatment …
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Contemporary OB/GYN week in review: HSDD treatment, PAS guidelines, and more
25 Jul 2025 23:30 GMT
… Flibanserin is the first and only pill approved by the FDA for the treatment … and CEO of Sprout Pharmaceuticals. “Priority Review brings … Endometriosis is a serious medical and gynecological condition … University of California Irvine Medical Center. “Currently, …
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FDA grants priority review to expanded indication of flibanserin in HSDD
24 Jul 2025 22:06 GMT
… use of the non-hormonal medication in women who have gone … ) trials.
Prior Approval of Flibanserin
Flibanserin was FDA approved in 2015 for the treatment of … ;drugsatfda_docs/label/2015/022526lbl.pdf
3. Sprout Pharmaceuticals …
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FDA grants Priority Review to flibanserin for treating postmenopausal HSDD
24 Jul 2025 15:42 GMT
… Flibanserin is the first and only pill approved by the FDA for the treatment … trials in women’s sexual health. Health Canada approved the medication … taking flibanserin to reduce risks.
Doctors should … postmenopausal women. Sprout Pharmaceuticals. July 24, 2025 …
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FDA Grants Fast Track Designation for Sprout's Flibanserin to Treat HSDD in Postmenopausal Women
24 Jul 2025 23:46 GMT
… company noted that the drug has already been approved … have no option for treatment.
“This is about … by 3 randomized controlled trials demonstrating modest but statistically … FDA approval of ADDYI (flibanserin 100 MG). News release. Sprout Pharmaceuticals. …
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She Wears Bright Pink And Fights For Women’s Pleasure. Now, The Medical World Is Listening.
18 Jul 2025 11:19 GMT
… ’s main drug was a testosterone treatment.)
During a … the “best sexual medicine doctors in the world” … Pharmaceuticals, founded Sprout Pharmaceuticals, and began the grueling six-year FDA … temple.
Many antidepressants and antianxiety medications, such as …
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FDA Posts Slate of Seven Warning Letters Following Company Inspections
13 Jun 2025 03:25 GMT
… finished pharmaceuticals; according to FDA, these products include over-the-counter drug products … flibanserin, marketed as Addyi, within the meaning of the federal Food, Drug … sex pill for women”; while it has been indicated for treatment of …
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Sprout Pharmaceuticals, Inc. - 709942 - 05/29/2025
10 Jun 2025 14:29 GMT
… Chief Executive Officer
Sprout Pharmaceuticals, Inc.
4350 … Drug Promotion (OPDP)
United States
RE: NDA 022526
ADDYI (flibanserin … Pill for Women…” (screenshot)
“Addyi is the first FDA-approved treatment … of a medication or other drug substance.
Additionally …
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FDA Ratchets Enforcement on Social Media Promotion in New Warning Letter
12 Jun 2025 18:07 GMT
… Drug Administration (“FDA”) Office of Prescription Drug … ADDYI® (flibanserin) (“Addyi”). According to FDA, … pharmaceutical industry.
Promotional Content
Addyi is the first FDA-approved medication … pill for women” and “Addyi is the first FDA-approved treatment …