Infertility

• FDA label_change · 2016-11-15
  FDA Approved: FOLLISTIM AQ — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for FOLLISTIM AQ (follitropin) by Organon LLC, typically updating the product’s labeling.

• FDA label_change · 2015-10-21
  FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for NOVAREL (chorionic gonadotropin) from Ferring Pharmaceuticals, updating the product labeling.

• FDA label_change · 2014-12-19
  FDA Approved: GANIRELIX ACETATE — Supplemental Application (Organon LLC)

  FDA approved Organon LLC's supplemental application for Ganirelix acetate.

• FDA label_change · 2014-02-28
  FDA Approved: PREGNYL — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for PREGNYL (choriogonadotropin alfa) filed by Organon LLC, resulting in labeling changes for the pr…

• FDA label_change · 2014-01-30
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (follitropin alfa) to update labeling and/or indications under the existing license.

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• FDA label_change · 2013-10-16
  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) submitted by EMD Serono, updating the product labeling f…

• FDA label_change · 2013-04-04
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for GONAL-F (follitropin alfa) from EMD Serono, Inc., resulting in changes to the product labeli…

• FDA label_change · 2013-03-15
  FDA Approved: CETROTIDE — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for Cetrotide (cetrotrelix acetate) from EMD Serono, Inc., typically resulting in labeling changes u…

• FDA label_change · 2013-01-18
  FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for GONAL-F (follitropin alfa) to update the labeling for the product.