Infertility

• FDA approval · 2013-01-29
  FDA Approved: CETROTIDE — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for Cetrotide (cetrorelix acetate) submitted by EMD Serono, Inc. This action reflects regulatory aut…

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

  The FDA approved a supplemental application for GONAL-F RFF REDI-JECT, introducing an auto-injector delivery system for follitropin.

• 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 · 2012-12-10
  FDA Approved: OVIDREL — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for OVIDREL (chorionic gonadotropin alfa) from EMD Serono, Inc.

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• FDA approval · 2011-08-22
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for FOLLISTIM AQ (follitropin) from Organon LLC. This action updates the product's existing appr…

• FDA approval · 2011-04-15
  FDA Approved: PREGNYL — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for PREGNYL (chorionic gonadotropin alfa) from Organon LLC.

• FDA approval · 2011-04-15
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for NOVAREL (chorionic gonadotropin) from Ferring Pharmaceuticals. This action involves changes to l…

• FDA approval · 2011-04-15
  FDA Approved: CHORIONIC GONADOTROPIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for chorionic gonadotropin (Chorionic Gonadotropin) by Fresenius Kabi USA, LLC.

• 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.

• FDA approval · 2010-06-02
  FDA Approved: OVIDREL — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for OVIDREL (chorionic gonadotropin alfa) filed by EMD Serono, Inc., resulting in updated labeli…

• FDA approval · 2009-06-03
  FDA Approved: ENDOMETRIN — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for ENDOMETRIN (progesterone) submitted by Ferring Pharmaceuticals.

• FDA approval · 2008-06-30
  FDA Approved: GANIRELIX ACETATE — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for GANIRELIX ACETATE by Organon LLC, indicating an approved update to the product's labeling. This …

• FDA approval · 2008-06-10
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

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

• FDA approval · 2008-04-04
  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 · 2008-02-26
  FDA Approved: ENDOMETRIN — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for ENDOMETRIN (progesterone) submitted by Ferring Pharmaceuticals.

• FDA approval · 2007-12-18
  FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F RFF REDI-JECT (follitropin), a ready-to-use auto-injector form of follitropin by EMD…

• FDA approval · 2007-12-06
  FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)

  FDA approves a supplemental application for GONAL-F RFF REDI-JECT (follitropin alfa), approving a redesigned auto-injector device. The appro…

• FDA approval · 2007-07-30
  FDA Approved: OVIDREL — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for OVIDREL (chorionic gonadotropin alfa), updating its labeling to support triggering ovulation…

• FDA approval · 2007-06-21
  FDA Approved: ENDOMETRIN — Original Application (Ferring Pharmaceuticals Inc.)

  The FDA approved ENDOMETRIN (progesterone) under an Original Application filed by Ferring Pharmaceuticals, marking its initial regulatory ap…