Major Depressive Disorder

• FDA approval · 2013-01-29
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for sertraline hydrochloride from Rising Pharma Holdings, Inc., indicating approval of changes to th…

• FDA approval · 2013-01-10
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for VIIBRYD (vilazodone hydrochloride), the antidepressant vilazodone.

• FDA approval · 2013-01-03
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

  The FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company.

• FDA approval · 2012-12-21
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for sertraline hydrochloride by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-12-18
  FDA Approved: PAXIL — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for Paxil (paroxetine hydrochloride) submitted by Apotex Corp.

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• FDA approval · 2012-12-18
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) submitted by Viatris Specialty LLC.

• FDA approval · 2012-12-14
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Viibryd (vilazodone hydrochloride) submitted by Allergan, Inc., reflecting an approved updat…

• FDA approval · 2012-12-11
  FDA Approved: REMERON — Supplemental Application (Organon LLC)

  FDA approves a supplemental application for REMERON (mirtazapine) submitted by Organon LLC.

• FDA approval · 2012-12-11
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Vertical Pharmaceuticals, LLC, expanding the drug’s approved …

• FDA approval · 2012-12-03
  FDA Approved: CELEXA — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for Celexa (citalopram) under NDA 020822.

• FDA approval · 2012-10-30
  FDA Approved: REMERON — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for REMERON (mirtazapine) submitted by Organon LLC.

• FDA approval · 2012-10-26
  FDA Approved: PAMELOR — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for PAMELOR (nortriptyline hydrochloride) submitted by SpecGx LLC.

• FDA approval · 2012-10-24
  FDA Approved: IMIPRAMINE HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  The FDA approved the original ANDA for a generic imipramine hydrochloride product from Leading Pharma, LLC, enabling marketing of a generic …

• FDA approval · 2012-10-01
  FDA Approved: FLUOXETINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original (ANDA) application for fluoxetine from Heritage Pharmaceuticals (d/b/a Avet), confirming a generic formulation of …

• FDA approval · 2012-09-27
  FDA Approved: FLUOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fluoxetine from Aurobindo Pharma Limited, allowing the generic product to be marketed under the …

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approval of a supplemental application for venlafaxine from BluePoint Laboratories (ANDA).

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for venlafaxine hydrochloride from Aurobindo Pharma Limited, resulting in approval of a generic venl…

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride submitted by Teva Pharmaceuticals USA, Inc., resulting in changes to t…

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for venlafaxine hydrochloride submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-09-19
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2012-09-12
  FDA Approved: ESCITALOPRAM — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals' original application for escitalopram oxalate, granting approval of a generic escitalopram pr…

• FDA approval · 2012-09-11
  FDA Approved: ESCITALOPRAM OXALATE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approves Quallent Pharmaceuticals Health LLC's original application for escitalopram oxalate as a generic antidepressant indicated for m…

• FDA approval · 2012-09-11
  FDA Approved: ESCITALOPRAM — Original Application (Accord Healthcare Inc.)

  FDA approves Accord Healthcare Inc.'s original application for generic escitalopram, expanding availability of the antidepressant.

• FDA approval · 2012-09-11
  FDA Approved: ESCITALOPRAM OXALATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves Macleods Pharmaceuticals Limited's original application for escitalopram oxalate, a generic antidepressant, providing a generic…