Obesity

• FDA approval · 2025-10-14
  FDA Approved: SAXENDA — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for SAXENDA (liraglutide) from Novo Nordisk. This action signifies approval of a supplemental ND…

• FDA approval · 2025-10-14
  FDA Approved: WEGOVY — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Wegovy (semaglutide) from Novo Nordisk.

• FDA approval · 2025-09-25
  FDA Approved: ZEPBOUND — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for ZEPBOUND (tirzepatide) from Eli Lilly and Company.

• FDA approval · 2025-08-27
  FDA Approved: LIRAGLUTIDE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva's liraglutide generic under Original Application (ANDA 214568). The approval covers the same indications as the reference …

• FDA approval · 2025-08-15
  FDA Approved: WEGOVY — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Wegovy (semaglutide) from Novo Nordisk.

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• EMA approval · 2025-07-31
  EMA Authorised: Saxenda (liraglutide) — Novo Nordisk A/S

  EMA authorised Saxenda (liraglutide) for obesity and overweight, with Novo Nordisk A/S as the marketing authorization holder.

• FDA approval · 2025-07-24
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for phentermine hydrochloride submitted by Chartwell RX, LLC. This approval pertains to a generic pr…

• FDA approval · 2025-07-22
  FDA Approved: LIRAGLUTIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic liraglutide (Original Application), making a generic injectable GLP-1 receptor agonist avail…

• FDA approval · 2025-07-11
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the phentermine and topiramate combination submitted by Prasco Laboratories, indicating an a…

• FDA approval · 2025-06-12
  FDA Approved: PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' generic phentermine/topiramate extended-release (ANDA) for obesity, marking the generic approval of t…

• FDA approval · 2025-05-29
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for phentermine and topiramate by Teva Pharmaceuticals for weight-management use.

• FDA approval · 2025-04-17
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's supplemental application to market a generic phentermine/topiramate combination for weight management in adults with obe…

• FDA approval · 2025-04-02
  FDA Approved: LIRAGLUTIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved the original application for liraglutide (Meitheal Pharmaceuticals Inc.), enabling marketing of a liraglutide injection in the …

• FDA approval · 2025-03-28
  FDA Approved: METHAMPHETAMINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for methamphetamine hydrochloride from Hikma Pharmaceuticals USA Inc., validating an approved change…

• FDA approval · 2024-12-23
  FDA Approved: LIRAGLUTIDE — Original Application (Hybio Pharmaceutical Co., Ltd. (Pingshan Factory))

  FDA approved an original application for liraglutide manufactured by Hybio Pharmaceutical Co., Ltd. (Pingshan Factory).

• EMA approval · 2024-12-05
  EMA Authorised: Alli (previously Orlistat GSK) (orlistat) — Haleon Ireland Dungarvan Limited

  The EMA authorised Alli (orlistat) for obesity in the European Union. The marketing authorization holder is Haleon Ireland Dungarvan Limited…

• FDA approval · 2024-11-27
  FDA Approved: WEGOVY — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Wegovy (semaglutide) from Novo Nordisk.

• FDA approval · 2024-11-19
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for phentermine and topiramate by Prasco Laboratories, supporting additional regulatory authorizatio…

• FDA approval · 2024-11-01
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for liraglutide, updating the drug's labeling/indication.

• FDA approval · 2024-11-01
  FDA Approved: SAXENDA — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Saxenda (liraglutide) submitted by Novo Nordisk.

• FDA approval · 2024-11-01
  FDA Approved: WEGOVY — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Wegovy (semaglutide) from Novo Nordisk, supporting updated labeling or an expanded indication.

• FDA approval · 2024-10-18
  FDA Approved: ZEPBOUND — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application to expand ZEPBOUND's label for weight management in adults with obesity or overweight.

• FDA approval · 2024-09-13
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a generic fixed-dose combination of phentermine and topiramate. This ap…

• FDA approval · 2024-06-25
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's generic phentermine and topiramate for obesity as an original application.

• FDA approval · 2024-06-06
  FDA Approved: METHAMPHETAMINE HYDROCHLORIDE — Supplemental Application (Mayne Pharma Commercial LLC)

  FDA approved a supplemental application for methamphetamine hydrochloride from Mayne Pharma Commercial LLC.