Attention Deficit Hyperactivity Disorder

• FDA approval · 2007-03-08
  FDA Approved: FOCALIN — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for FOCALIN (dexmethylphenidate hydrochloride) submitted by Sandoz Inc.

• FDA approval · 2007-02-23
  FDA Approved: VYVANSE — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved Vyvanse (lisdexamfetamine dimesylate) from Takeda as the original NDA (NDA021977) for the treatment of attention-deficit/hypera…

• FDA approval · 2006-10-19
  FDA Approved: STRATTERA — Supplemental Application (Eli Lilly and Company)

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

• FDA approval · 2006-09-07
  FDA Approved: CONCERTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)

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

• FDA approval · 2006-08-10
  FDA Approved: METHYLIN — Supplemental Application (SHIONOGI INC.)

  The FDA approved a supplemental application for METHYLIN (methylphenidate hydrochloride) from Shionogi, resulting in labeling updates.

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• FDA approval · 2006-08-10
  FDA Approved: DEXEDRINE SPANSULE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Dexedrine Spansule (dextroamphetamine sulfate) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2006-08-08
  FDA Approved: METHYLPHENIDATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for methylphenidate from Sandoz Inc, updating an already approved product.

• FDA approval · 2006-08-08
  FDA Approved: RITALIN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Ritalin (methylphenidate hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2006-08-01
  FDA Approved: FOCALIN XR — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2006-07-27
  FDA Approved: METHYLPHENIDATE TRANSDERMAL SYSTEM — Supplemental Application (PADAGIS US LLC)

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

• FDA approval · 2006-07-26
  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 product containing dextroamphetamine saccharate, amphetamine aspartat…

• FDA approval · 2006-06-16
  FDA Approved: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE — Supplemental Application (Prasco Laboratories)

  FDA granted a supplemental approval to Prasco Laboratories for a mixed amphetamine salts product containing dextroamphetamine and amphetamin…