Attention Deficit Hyperactivity Disorder

• FDA approval · 2013-06-07
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for RITALIN (methylphenidate hydrochloride) from Novartis Pharmaceuticals Corporation, signaling an …

• FDA approval · 2013-06-06
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  FDA approved a supplemental application for the methylphenidate transdermal system (methylphenidate) submitted by PADAGIS US LLC.

• FDA approval · 2013-06-04
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for methylphenidate hydrochloride CD (methylphenidate hydrochloride) from Lannett Company, Inc. unde…

• FDA approval · 2013-05-29
  FDA Approved: DEXTROAMPHETAMINE — Original Application (Cranbury Pharmaceuticals, LLC)

  FDA approves Cranbury Pharmaceuticals' original ANDA for dextroamphetamine, a generic stimulant indicated for attention-deficit/hyperactivit…

• FDA approval · 2013-05-20
  FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Strattera (atomoxetine hydrochloride) from Eli Lilly and Company, likely resulting in changes to…

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• FDA approval · 2013-05-15
  FDA Approved: QUILLIVANT XR — Supplemental Application (NextWave Pharmaceuticals, Inc)

  FDA approved a supplemental application for QUILLIVANT XR, indicating a modification or addition to the existing NDA for this methylphenidat…

• FDA approval · 2013-05-09
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  FDA approved a supplemental application for the methylphenidate transdermal system, submitted by PADAGIS US LLC.

• FDA approval · 2013-05-06
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate submitted by Sandoz Inc under NDA 021284, marking an additional approval for the…

• FDA approval · 2013-05-06
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE CD — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for methylphenidate hydrochloride CD from Lannett Company, Inc., authorizing its marketing as a …

• FDA approval · 2013-05-03
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CONCERTA (methylphenidate hydrochloride) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2013-03-12
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) from Mylan Institutional LLC.

• FDA approval · 2013-03-08
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a generic combination of amphetamine salts (dextroamphetamine saccharat…

• FDA approval · 2013-02-20
  FDA Approved: INTUNIV — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for INTUNIV (guanfacine) from Takeda Pharmaceuticals America, Inc., marking an update to the product…

• FDA approval · 2013-01-17
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (TruPharma, LLC)

  FDA approved a supplemental application for clonidine hydrochloride from TruPharma, LLC. This action indicates regulatory approval of a supp…

• FDA approval · 2013-01-16
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for clonidine hydrochloride from Actavis Pharma, Inc., indicating an approved modification to an…

• FDA approval · 2013-01-11
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) from Mylan Institutional LLC, adding to the existing approved…

• FDA approval · 2012-12-28
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE — Original Application (SpecGx LLC)

  FDA approved a generic extended-release methylphenidate hydrochloride product under an original ANDA filed by SpecGx LLC.

• FDA approval · 2012-12-19
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC, indicating regulatory approval for an existing ge…

• FDA approval · 2012-12-19
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methylphenidate hydrochloride from SpecGx LLC. The approval confirms the generic product's appro…

• FDA approval · 2012-11-21
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

  The FDA approved a supplemental application for the methylphenidate transdermal system (methylphenidate) submitted by PADAGIS US LLC.

• FDA approval · 2012-11-19
  FDA Approved: VYVANSE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Vyvanse (lisdexamfetamine dimesylate) submitted by Takeda Pharmaceuticals America, Inc., res…

• FDA approval · 2012-10-05
  FDA Approved: GUANFACINE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s Guanfacine as an original generic application (ANDA 200881), authorizing the manufacture and marketing o…

• FDA approval · 2012-09-27
  FDA Approved: QUILLIVANT XR — Original Application (NextWave Pharmaceuticals, Inc)

  The FDA approved QUILLIVANT XR (methylphenidate hydrochloride) from NextWave Pharmaceuticals in an Original Application, indicating approval…

• FDA approval · 2012-08-16
  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 · 2012-07-13
  FDA Approved: METHYLPHENIDATE HYDROCHLORIDE (LA) — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved the original application for methylphenidate hydrochloride (LA) from Teva Pharmaceuticals USA, Inc. as a long-acting generic st…