Major Depressive Disorder

• FDA approval · 2017-06-12
  FDA Approved: BUPROPION HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Bupropion hydrochloride from Aurobindo Pharma Limited, granting generic drug status for this API…

• FDA approval · 2017-06-12
  FDA Approved: BUPROPION HYDROCHLORIDE (XL) — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Bupropion hydrochloride extended-release (XL) from Exelan Pharmaceuticals Inc.

• FDA approval · 2017-06-01
  FDA Approved: MIRTAZAPINE — Original Application (SQUARE PHARMACEUTICALS LIMITED)

  FDA approved Square Pharmaceuticals Limited's generic version of mirtazapine for the treatment of major depressive disorder, marking the ori…

• FDA approval · 2017-05-18
  FDA Approved: DULOXETINE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original application for duloxetine, enabling the marketing of a generic duloxetine product.

• FDA approval · 2017-05-17
  FDA Approved: ESCITALOPRAM OXALATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for escitalopram oxalate, a generic version of escitalopram used to treat major de…

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• FDA approval · 2017-05-17
  FDA Approved: QUETIAPINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' generic quetiapine (quetiapine) for the treatment of schizophrenia and bipolar disorder, expanding acces…

• FDA approval · 2017-05-09
  FDA Approved: QUETIAPINE FUMARATE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's generic quetiapine fumarate under Original Application (ANDA090681) to bring a quetiapine fumarate product …

• FDA approval · 2017-05-04
  FDA Approved: APLENZIN — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental NDA for APLENZIN (bupropion hydrobromide) from Bausch Health US, LLC. The approval involves a supplemental submi…

• FDA approval · 2017-04-28
  FDA Approved: PAROXETINE — Supplemental Application (Padagis US LLC)

  The FDA has approved a supplemental application for paroxetine filed by Padagis US LLC. This notice indicates FDA approval of an amendment t…

• FDA approval · 2017-04-27
  FDA Approved: DESVENLAFAXINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's supplemental application for desvenlafaxine succinate, a generic version of desvenlafaxin…

• FDA approval · 2017-04-17
  FDA Approved: BUPROPION HYDROCHLORIDE SR — Supplemental Application (Dr. Reddys Laboratories Inc.)

  The FDA approved a supplemental application for Bupropion hydrochloride SR from Dr. Reddy's Laboratories Inc., enabling marketing of this ge…

• FDA approval · 2017-04-12
  FDA Approved: BUPROPION HYDROCHLORIDE (XL) — Original Application (ScieGen Pharmaceuticals,Inc.)

  FDA approved ScieGen Pharmaceuticals' generic bupropion hydrochloride extended-release (XL) for the same indications as the reference produc…

• FDA approval · 2017-04-06
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for duloxetine submitted by Zydus Lifesciences Limited, advancing the regulatory status of the g…

• FDA approval · 2017-04-05
  FDA Approved: FLUOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for fluoxetine hydrochloride (fluoxetine) as a generic drug.

• FDA approval · 2017-03-29
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for aripiprazole, enabling the marketing of a generic aripiprazole product.

• FDA approval · 2017-03-24
  FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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

• FDA approval · 2017-03-24
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved a generic venlafaxine hydrochloride product from Westminster Pharmaceuticals, LLC under an Original Application. This approval …

• FDA approval · 2017-03-23
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for duloxetine hydrochloride from Macleods Pharmaceuticals Limited, authorizing a generic version of d…

• FDA approval · 2017-03-10
  FDA Approved: TRINTELLIX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for TRINTELLIX (vortioxetine) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2017-02-23
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) from AstraZeneca Pharmaceuticals LP, updating or expanding its labeling…

• FDA approval · 2017-02-23
  FDA Approved: REXULTI — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved a supplemental application for Rexulti (brexpiprazole) submitted by Otsuka America Pharmaceutical, Inc. The approval updates th…

• FDA approval · 2017-02-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for aripiprazole, enabling the generic version to be marketed.

• FDA approval · 2017-02-23
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application to authorize a generic aripiprazole product by Lannett Company, Inc. under ANDA204171.

• FDA approval · 2017-02-01
  FDA Approved: ARIPIPRAZOLE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for aripiprazole (generic ARIPIPRAZOLE) from Amneal Pharmaceuticals LLC, authorizing the generic for…

• FDA approval · 2017-01-20
  FDA Approved: PAROXETINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for Paroxetine, a generic selective serotonin reuptake inhibitor. The approval expa…