Hypogonadotropic Hypogonadism

• FDA approval · 2024-02-07
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for FOLLISTIM AQ (FOLLITROPIN) from Organon LLC. The action updates the regulatory status for the pr…

• FDA approval · 2023-11-21
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc.

• FDA approval · 2020-12-31
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (Follitropin alfa) submitted by EMD Serono, Inc.

• FDA approval · 2016-12-15
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for FOLLISTIM AQ (follitropin) from Organon LLC.

• FDA approval · 2015-11-19
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (follitropin alfa) from EMD Serono, Inc. This approval may involve labeling or indicatio…

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• FDA approval · 2015-02-09
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc.

• FDA approval · 2015-01-20
  FDA Approved: MENOPUR — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for MENOPUR (menotropins) submitted by Ferring Pharmaceuticals Inc.

• FDA approval · 2014-01-29
  FDA Approved: CHORIONIC GONADOTROPIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for CHORIONIC GONADOTROPIN from Fresenius Kabi USA, LLC.

• FDA approval · 2013-12-19
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc. The action updates the product's la…

• FDA approval · 2013-09-20
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) from EMD Serono, Inc., authorizing changes to its labeling and/or…

• FDA approval · 2013-02-08
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (folitropin alfa) submitted by EMD Serono, Inc.

• FDA approval · 2013-01-31
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc.

• FDA approval · 2013-01-31
  FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F RFF REDI-JECT (follitropin) submitted by EMD Serono, Inc. The action approves changes to…

• FDA approval · 2013-01-23
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc., typically to modify labeling or expand…

• FDA approval · 2013-01-11
  FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F RFF REDI-JECT, a redesigned auto-injector formulation of follitropin alfa, expanding…

• FDA approval · 2010-06-28
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for FOLLISTIM AQ (folllitropin) from Organon LLC.