Infertility

• FDA approval · 2024-04-16
  FDA Approved: CETRORELIX ACETATE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s original ANDA for cetrorelix acetate for injection, a GnRH antagonist used to prevent premature ovulation du…

• FDA approval · 2024-03-20
  FDA Approved: GANIRELIX ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for Ganirelix Acetate submitted by Meitheal Pharmaceuticals Inc.

• FDA approval · 2024-03-20
  FDA Approved: GANIRELIX ACETATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Ganirelix Acetate submitted by Fresenius Kabi USA, LLC. This action updates the regulatory statu…

• 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 · 2023-12-04
  FDA Approved: CETROTIDE — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for CETROTIDE (cetrorelix acetate) filed by EMD Serono, Inc.

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• 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 · 2023-11-16
  FDA Approved: GANIRELIX ACETATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Ganirelix Acetate as a new generic product under an original ANDA from Lupin Pharmaceuticals to prevent premature ovulation dur…

• FDA approval · 2023-10-02
  FDA Approved: CHORIONIC GONADOTROPIN — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for Chorionic Gonadotropin submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2023-05-23
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for NOVAREL (chorionic gonadotropin) from Ferring Pharmaceuticals, indicating a regulatory update to…

• FDA approval · 2023-03-21
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

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

• FDA approval · 2023-03-02
  FDA Approved: PREGNYL — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Pregnyl (chorionic gonadotropin alfa) submitted by Organon LLC.

• FDA approval · 2023-02-28
  FDA Approved: GANIRELIX ACETATE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's original application for ganirelix acetate, a GnRH antagonist used to prevent premature LH surge …

• FDA approval · 2022-08-12
  FDA Approved: CETRORELIX — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original ANDA for cetrorelix acetate, a GnRH antagonist. It provides a generic option to prevent premature ovulation dur…

• EMA approval · 2022-07-20
  EMA Authorised: Ganirelix Gedeon Richter (ganirelix acetate) — Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)

  Approval status indicates ganirelix acetate (Ganirelix Gedeon Richter) has authorisation for use in assisted reproductive techniques, ovulat…

• FDA approval · 2022-06-06
  FDA Approved: GANIRELIX ACETATE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals Inc.'s original ANDA for ganirelix acetate, a GnRH antagonist used to prevent premature LH surge d…

• FDA approval · 2022-04-07
  FDA Approved: GANIRELIX ACETATE — Original Application (Amphastar Pharmaceuticals, Inc.)

  FDA approved Ganirelix acetate as an Original Application generic to prevent premature ovulation during controlled ovarian stimulation in as…

• FDA approval · 2021-03-16
  FDA Approved: FYREMADEL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for FYREMADEL (ganirelix acetate) by Ferring Pharmaceuticals 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 · 2020-10-22
  FDA Approved: GANIRELIX ACETATE — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for ganirelix acetate submitted by Organon LLC.

• FDA approval · 2019-05-03
  FDA Approved: FYREMADEL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for FYREMADEL (ganirelix acetate) submitted by Ferring Pharmaceuticals Inc.

• FDA approval · 2018-11-30
  FDA Approved: FYREMADEL — Original Application (Ferring Pharmaceuticals Inc.)

  The FDA approved FYREMADEL (ganirelix acetate) from Ferring Pharmaceuticals Inc., marking the original approval of this GnRH antagonist for …

• FDA approval · 2018-08-01
  FDA Approved: CABERGOLINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Cabergoline (original application) from Ingenus Pharmaceuticals, LLC, expanding access to this dopamine agonist under an ANDA. …

• FDA approval · 2017-12-22
  FDA Approved: CETROTIDE — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for Cetrotide (cetrorelix acetate) submitted by EMD Serono, Inc.

• FDA approval · 2017-11-06
  FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F RFF REDI-JECT, adding a prefilled auto-injector delivery option for follitropin.

• FDA approval · 2017-01-09
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for NOVAREL (gonadotropin, chorionic) submitted by Ferring Pharmaceuticals Inc.