Obesity

• FDA approval · 2012-12-03
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for liraglutide submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2012-11-01
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental NDA for phentermine/topiramate from Prasco Laboratories. This action updates the labeling for the combinatio…

• FDA approval · 2012-09-28
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (Precision Dose Inc.)

  The FDA approved the original application for a generic phentermine hydrochloride product, manufactured by Precision Dose Inc., for obesity …

• FDA approval · 2012-07-17
  FDA Approved: PHENTERMINE AND TOPIRAMATE — Original Application (Prasco Laboratories)

  FDA approves an original application for a phentermine/topiramate combination product from Prasco Laboratories for weight management in adul…

• FDA approval · 2012-05-23
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for phentermine hydrochloride from Sun Pharmaceutical Industries, Inc. to modify or add aspects of t…

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• FDA approval · 2012-02-10
  FDA Approved: PHENDIMETRAZINE TARTRATE — Supplemental Application (Acertis Pharmaceuticals, LLC)

  FDA approved a supplemental application for phendimetrazine tartrate from Acertis Pharmaceuticals, LLC, expanding its regulatory approval fo…

• FDA approval · 2012-01-20
  FDA Approved: XENICAL — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for XENICAL (orlistat) submitted by H2-Pharma LLC, updating the existing NDA.

• FDA approval · 2011-10-24
  FDA Approved: DIETHYLPROPION HYDROCHLORIDE ER — Original Application (OMNIVIUM PHARMACEUTICALS LLC.)

  The FDA approved a generic extended-release diethylpropion hydrochloride product for the short-term management of obesity as an adjunct to d…

• FDA approval · 2011-07-18
  FDA Approved: DIETHYLPROPION HYDROCHLORIDE — Original Application (Chartwell RX, LLC.)

  The FDA approved Chartwell RX, LLC's generic diethylpropion hydrochloride under ANDA 200177 for short-term weight management in obesity.

• FDA approval · 2011-05-18
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva Pharmaceuticals USA, Inc.'s supplemental application for liraglutide.

• FDA approval · 2011-03-10
  FDA Approved: ALLI — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ALLI (orlistat) submitted by Haleon US Holdings LLC. The action updates the drug's labeling as p…

• FDA approval · 2011-02-04
  FDA Approved: ALLI — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ALLI (orlistat) from Haleon US Holdings LLC.

• FDA approval · 2011-01-31
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (TAGI Pharma, Inc.)

  FDA approved the original application for phentermine hydrochloride, a generic weight-management drug manufactured by TAGI Pharma, Inc. for …

• FDA approval · 2010-12-22
  FDA Approved: DIETHYLPROPION HYDROCHLORIDE — Original Application (KVK-TECH, INC)

  FDA approved diethylpropion hydrochloride as an Original Application for obesity management, with KVK-TECH, INC as the applicant.

• FDA approval · 2010-12-22
  FDA Approved: LIRAGLUTIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for liraglutide. This action updates the regulatory status of the lir…

• FDA approval · 2010-09-22
  FDA Approved: ALLI — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Alli (orlistat) submitted by Haleon US Holdings LLC.

• FDA approval · 2010-08-31
  FDA Approved: PHENDIMETRAZINE TARTRATE — Original Application (KVK-TECH, INC)

  The FDA approved the original application for phendimetrazine tartrate from KVK-Tech, Inc., providing a generic option for this weight-loss …

• FDA approval · 2010-07-20
  FDA Approved: BENZPHETAMINE HYDROCHLORIDE — Original Application (KVK-TECH, INC)

  FDA approved benzphetamine hydrochloride (KVK-TECH, INC) under an Original Application.

• FDA approval · 2010-05-25
  FDA Approved: XENICAL — Supplemental Application (H2-Pharma LLC)

  FDA approved a supplemental application for Xenical (orlistat) submitted by H2-Pharma LLC.

• FDA approval · 2010-04-21
  FDA Approved: METHAMPHETAMINE HYDROCHLORIDE — Original Application (Mayne Pharma Commercial LLC)

  FDA approved a generic methamphetamine hydrochloride product under an original ANDA from Mayne Pharma Commercial LLC, applicable to ADHD and…

• FDA approval · 2009-02-11
  FDA Approved: XENICAL — Supplemental Application (H2-Pharma LLC)

  The FDA approved a supplemental application for XENICAL (orlistat), submitted by H2-Pharma LLC.

• FDA approval · 2008-04-24
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (KVK-TECH, Inc.)

  FDA approves a generic version of phentermine hydrochloride (KVK-TECH, Inc.) under Original Application, enabling market entry for obesity m…

• FDA approval · 2008-03-31
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (KVK-TECH, Inc.)

  FDA approved the original application for phentermine hydrochloride, a generic weight-management drug manufactured by KVK-Tech, Inc.

• FDA approval · 2008-03-31
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (KVK-Tech, Inc.)

  FDA approval of KVK-Tech's generic phentermine hydrochloride (original application) for short-term weight management in obesity.

• FDA approval · 2008-03-21
  FDA Approved: PHENTERMINE HYDROCHLORIDE — Original Application (KVK-Tech, Inc.)

  The FDA approved KVK-Tech, Inc.'s original application for phentermine hydrochloride, a generic formulation used for weight management.