Hypogonadism

• FDA approval · 2026-03-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)

  The FDA approved a supplemental application for TESTOSTERONE submitted by Dr. Reddy's Laboratories, Inc. The product is used for testosteron…

• EMA approval · 2025-12-18
  EMA Authorised: Puregon (follitropin beta) — Organon N.V.

  The EMA authorised Puregon (follitropin beta) for infertility and hypogonadism, with Organon N.V. listed as the marketing authorization hold…

• FDA approval · 2025-12-17
  FDA Approved: TESTOSTERONE GEL, 1% — Supplemental Application (Encube Ethicals, Inc.)

  The FDA approved a supplemental application for TESTOSTERONE GEL, 1% from Encube Ethicals, Inc., to maintain/expand approval for testosteron…

• FDA approval · 2025-10-15
  FDA Approved: ESTROGENS, CONJUGATED — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for a generic conjugated estrogens product from Ingenus Pharmaceuticals, LLC, marking entry of this ge…

• FDA approval · 2025-09-12
  FDA Approved: JATENZO — Supplemental Application (TOLMAR Inc.)

  The FDA approved Tolmar Inc.'s supplemental application for JATENZO (testosterone undecanoate).

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• FDA approval · 2025-07-21
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for Testosterone Cypionate from Alvogen Inc., under ANDA207742.

• FDA approval · 2025-07-15
  FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for testosterone submitted by Actavis Pharma, Inc., authorizing changes to the product under an …

• FDA approval · 2025-07-11
  FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for TESTIM (testosterone) submitted by Endo USA, Inc.

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for TESTOSTERONE, updating labeling for the generic testosterone product.

• FDA approval · 2025-07-11
  FDA Approved: JATENZO — Supplemental Application (TOLMAR Inc.)

  FDA approved a supplemental application for JATENZO (testosterone undecanoate) from Tolmar Inc., signaling an approval of a change to the ND…

• FDA approval · 2025-07-11
  FDA Approved: XYOSTED — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental application for XYOSTED (testosterone enanthate) from Antares Pharma, Inc.

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for TESTOSTERONE from Cipla USA Inc. under an ANDA.

• FDA approval · 2025-07-11
  FDA Approved: TLANDO — Supplemental Application (Verity Pharmaceuticals Inc.)

  The FDA approved a supplemental application for TLANDO (testosterone undecanoate) submitted by Verity Pharmaceuticals Inc.

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for TESTOSTERONE CYPIONATE submitted by Padagis US LLC. The approval confirms marketing authorizatio…

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE ENANTHATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for testosterone enanthate from Hikma Pharmaceuticals USA Inc. This action updates the regulatory st…

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's testosterone cypionate, enabling continued marketing of the generic testost…

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approves a supplemental application for TESTOSTERONE by Alembic Pharmaceuticals Inc., authorizing changes to the product's labeling.

• FDA approval · 2025-07-11
  FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for testosterone cypionate by Padagis US LLC. The document confirms regulatory action on the product…

• FDA approval · 2025-07-11
  FDA Approved: AZMIRO — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AZMIRO (testosterone cypionate) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2025-07-11
  FDA Approved: METHITEST — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for METHITEST (methyltestosterone) from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2025-07-11
  FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)

  FDA approved a supplemental application for ANDROGEL (testosterone) submitted by ASCEND Therapeutics U.S., LLC.

• FDA approval · 2025-07-11
  FDA Approved: NATESTO NASAL GEL — Supplemental Application (Acerus Pharmaceuticals Corporation)

  The FDA approved a supplemental application for NATESTO nasal gel (testosterone) submitted by Acerus Pharmaceuticals Corporation.

• FDA approval · 2025-07-11
  FDA Approved: VOGELXO — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for VogelXO (testosterone) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2025-07-11
  FDA Approved: METHYLTESTOSTERONE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Methyltestosterone submitted by ANI Pharmaceuticals, Inc. The action updates the drug's regulato…

• FDA approval · 2025-07-11
  FDA Approved: KYZATREX — Supplemental Application (Marius Pharmaceuticals)

  The FDA approved a supplemental application for KYZATREX (testosterone undecanoate) by Marius Pharmaceuticals. The action updates the existi…