Hypoactive Sexual Desire Disorder

• FDA approval · 2025-12-13
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ADDYI (flibanserin) submitted by Sprout Pharmaceuticals.

• FDA approval · 2021-09-29
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ADDYI (flibanserin) from Sprout Pharmaceuticals, resulting in an updated labeling for the pr…

• FDA approval · 2020-10-23
  FDA Approved: VYLEESI — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' supplemental application for VYLEESI (bremelanotide), a treatment for hypoactive sexual desire disorde…

• FDA approval · 2019-06-21
  FDA Approved: VYLEESI — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved VYLEESI (bremelanotide) under an original NDA for the treatment of hypoactive sexual desire disorder in premenopausal women.

• FDA approval · 2019-04-11
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ADDYI (flibanserin) submitted by Sprout Pharmaceuticals.

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• FDA approval · 2019-04-02
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ADDYI (flibanserin) by Sprout Pharmaceuticals, Inc., updating regulatory status for the product.

• FDA approval · 2017-06-16
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ADDYI (flibanserin) from Sprout Pharmaceuticals.

• FDA approval · 2016-04-08
  FDA Approved: ADDYI — Supplemental Application (Sprout Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for ADDYI (flibanserin) from Sprout Pharmaceuticals, Inc.

• FDA approval · 2015-08-18
  FDA Approved: ADDYI — Original Application (Sprout Pharmaceuticals, Inc.)

  FDA approved ADDYI (flibanserin) in Sprout Pharmaceuticals' original NDA for hypoactive sexual desire disorder in premenopausal women.