Diabetic Peripheral Neuropathy

• FDA approval · 2026-02-24
  FDA Approved: PREGABALIN — Original Application (FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED)

  FDA approved the original Abbreviated New Drug Application for pregabalin from Fourrts (India) Laboratories Private Limited, granting a gene…

• FDA approval · 2025-10-01
  FDA Approved: PREGABALIN — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved a supplemental application for pregabalin from Creekwood Pharmaceuticals LLC under ANDA213423.

• FDA approval · 2025-09-17
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  The FDA approved a supplemental application for pregabalin from Marksans Pharma Limited, resulting in approval of a generic pregabalin produ…

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental ANDA for pregabalin, authorizing the marketing of a generic pregabalin product.

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved a supplemental application for pregabalin from ScieGen Pharmaceuticals, Inc., confirming approval of the generic product under …

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• FDA approval · 2025-08-18
  FDA Approved: PREGABALIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Pregabalin submitted by Rising Pharma Holdings, Inc. under the approved ANDA.

• FDA approval · 2025-08-15
  FDA Approved: PREGABALIN — Supplemental Application (Indoco Remedies Limited)

  FDA approved a supplemental application for pregabalin from Indoco Remedies Limited, resulting in approval of a generic pregabalin product.

• FDA approval · 2025-07-21
  FDA Approved: PREGABALIN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for pregabalin. The approval enables the marketing of a generic pregabalin pr…

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for Pregabalin from Torrent Pharmaceuticals Limited, enabling the generic drug to be marketed.

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for pregabalin filed by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2025-02-21
  FDA Approved: PREGABALIN — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved a generic pregabalin product from Torrent Pharmaceuticals Limited (ANDA 206942) to be used for the same indications as the refe…

• FDA approval · 2024-12-19
  FDA Approved: PREGABALIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for pregabalin (generic pregabalin).

• FDA approval · 2024-12-12
  FDA Approved: PREGABALIN — Supplemental Application (Advagen Pharma Ltd.)

  FDA approved the supplemental application for pregabalin from Advagen Pharma Ltd., authorizing the generic product under an ANDA.

• FDA approval · 2024-08-23
  FDA Approved: PREGABALIN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for pregabalin from Solco Healthcare US, LLC, granting approval for changes related to the generic p…

• 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 · 2023-12-13
  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.

• 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 · 2023-06-26
  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…