Attention Deficit Hyperactivity Disorder

• FDA approval · 2010-09-23
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for a Sandoz generic combination of four amphetamine salt components (dextroamphetamine and amphetam…

• FDA approval · 2010-09-16
  FDA Approved: ATOMOXETINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original application for atomoxetine, a non-stimulant treatment for attention-deficit/hyperactivity disorder, manufactured …

• FDA approval · 2010-07-29
  FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for STRATTERA (atomoxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2010-07-28
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) submitted by Mylan Institutional LLC. This action confirms ap…

• FDA approval · 2010-06-29
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  FDA approved a supplemental application for the methylphenidate transdermal system for attention-deficit/hyperactivity disorder.

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• FDA approval · 2010-06-23
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for clonidine hydrochloride from Actavis Pharma, Inc. under ANDA070976.

• FDA approval · 2010-05-27
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for clonidine hydrochloride from Solco Healthcare LLC, approving the generic product's submission.

• FDA approval · 2010-05-10
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (TruPharma, LLC)

  The FDA approved a supplemental application for clonidine hydrochloride from TruPharma, LLC, as part of an existing ANDA.

• FDA approval · 2010-05-04
  FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) from Sandoz Inc.

• FDA approval · 2010-04-27
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc.

• 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 · 2010-04-05
  FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental NDA for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals America, detailing a label/indication …

• FDA approval · 2010-03-11
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (TruPharma, LLC)

  The FDA approved a supplemental application for clonidine hydrochloride (generic) from TruPharma, LLC.

• FDA approval · 2009-12-15
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  FDA approved a supplemental application for the Methylphenidate Transdermal System by PADAGIS US LLC.

• FDA approval · 2009-11-04
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for CONCERTA (methylphenidate hydrochloride).

• FDA approval · 2009-10-23
  FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for FOCALIN XR (dexmethylphenidate hydrochloride) by Sandoz Inc. The approval updates the existing N…

• FDA approval · 2009-09-02
  FDA Approved: INTUNIV — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved Intuniv (guanfacine) Extended-Release under Takeda's Original Application, establishing this product for the treatment of atten…

• FDA approval · 2009-08-11
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application from Teva Pharmaceuticals USA, Inc. for a combination of four amphetamine salts: dextroamphetamine s…

• FDA approval · 2009-06-03
  FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)

  FDA approves the supplemental application for Strattera (atomoxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2009-05-28
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved Epic Pharma LLC's supplemental application for a generic product containing four amphetamine salts: dextroamphetamine saccharat…

• FDA approval · 2009-05-22
  FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) from Takeda Pharmaceuticals America, Inc., authorizing cha…

• FDA approval · 2009-04-16
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental NDA for Methylphenidate Hydrochloride CD (generic from Lannett) to authorize its continued marketing as a methyl…

• FDA approval · 2009-01-14
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for CONCERTA (methylphenidate hydrochloride), updating labeling per the submission.

• FDA approval · 2008-11-12
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Prasco Laboratories to market a generic combination of amphetamine salts (dextroamphetamine sacc…

• FDA approval · 2008-10-17
  FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for FOCALIN XR submitted by Sandoz Inc, related to dexmethylphenidate hydrochloride (brand: FOCA…