Fibromyalgia

• FDA approval · 2024-07-11
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved ScieGen Pharmaceuticals' generic pregabalin product through an abbreviated new drug application.

• FDA approval · 2024-06-05
  FDA Approved: PREGABALIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves the supplemental ANDA for pregabalin from Aurobindo Pharma Limited, enabling the marketing of a generic pregabalin product in t…

• FDA approval · 2024-01-24
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  FDA approved a supplemental application for pregabalin submitted by Marksans Pharma Limited (ANDA 216197).

• FDA approval · 2023-12-19
  FDA Approved: DULOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for duloxetine hydrochloride from Aurobindo Pharma Limited, granting regulatory clearance for a gene…

• FDA approval · 2023-12-13
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) from Pfizer's Parke-Davis division.

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• FDA approval · 2023-12-13
  FDA Approved: LYRICA CR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for LYRICA CR (pregabalin) filed by Viatris Specialty LLC.

• FDA approval · 2023-08-18
  FDA Approved: SAVELLA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Savella (milnacipran hydrochloride) from Allergan, Inc.

• FDA approval · 2023-08-18
  FDA Approved: DRIZALMA SPRINKLE — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved Sun Pharmaceutical's supplemental NDA for Drizalma Sprinkle (duloxetine), adding a sprinkle-form formulation and related la…

• FDA approval · 2023-07-21
  FDA Approved: PREGABALIN — Supplemental Application (Eskayef Pharmaceuticals Limited)

  FDA approved a supplemental application for pregabalin (generic) submitted by Eskayef Pharmaceuticals Limited.

• FDA approval · 2023-07-12
  FDA Approved: PREGABALIN — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals Limited's original application for pregabalin, enabling a generic version of the drug.

• FDA approval · 2023-06-26
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for pregabalin under ANDA 207623, indicating approval of changes to this gene…

• FDA approval · 2023-06-21
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for pregabalin from Ascend Laboratories, LLC (ANDA207799), indicating approval of a supplemental fil…

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic pregabalin from Rising Pharma Holdings, Inc., authorizing its marketing for the same i…

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin from Alembic Pharmaceuticals Inc., enabling a generic version to be marketed.

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for pregabalin from Dr. Reddy's Laboratories Inc., authorizing a generic version under the approved …

• FDA approval · 2023-06-09
  FDA Approved: PREGABALIN CAPSULES, CV — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for Pregabalin Capsules, CV, enabling the marketing of a generic pregabalin capsule p…

• FDA approval · 2023-05-02
  FDA Approved: DULOXETINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application from Actavis Pharma, Inc. for duloxetine under ANDA 090776, granting approval for a supplemental cha…

• FDA approval · 2023-05-02
  FDA Approved: DULOXETINE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for duloxetine submitted by Solco Healthcare US, LLC (ANDA206653), authorizing a change related …

• FDA approval · 2023-03-31
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  The FDA approved a supplemental application from ScieGen Pharmaceuticals, Inc. for a generic pregabalin product. The approval covers the sam…

• FDA approval · 2023-03-24
  FDA Approved: PREGABALIN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for pregabalin from Solco Healthcare US, LLC under ANDA207883. The drug is indicated for neuropathic…

• FDA approval · 2023-03-24
  FDA Approved: PREGABALIN — Supplemental Application (Tris Pharma Inc)

  FDA approved a supplemental application for pregabalin submitted by Tris Pharma Inc.

• FDA approval · 2022-12-23
  FDA Approved: SAVELLA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Savella (milnacipran hydrochloride) submitted by Allergan, resulting in a labeling change for th…

• FDA approval · 2022-09-01
  FDA Approved: PREGABALIN — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original ANDA for pregabalin (generic pregabalin). This marks the approval of a generic version of p…

• FDA approval · 2022-07-29
  FDA Approved: DULOXETINE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for duloxetine filed by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2022-07-26
  FDA Approved: DULOXETINE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for DULOXETINE submitted by Quallent Pharmaceuticals Health LLC. The notice confirms regulatory …