Postherpetic Neuralgia

• 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 · 2023-08-07
  FDA Approved: GABAPENTIN — Supplemental Application (Ajenat Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Ajenat Pharmaceuticals LLC.

• FDA approval · 2023-08-02
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC.

• 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 · 2023-07-19
  FDA Approved: GABAPENTIN — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic gabapentin product from Rising Pharma Holdings, Inc. under an Original Application (ANDA217995).

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• 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 · 2023-05-12
  FDA Approved: GABAPENTIN — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs' generic Gabapentin original application. The approval covers its use for partial seizures and postherpetic neuralg…

• FDA approval · 2023-04-18
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• 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 · 2023-03-28
  FDA Approved: GABAPENTIN — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved an original application for a generic gabapentin product from Granules Pharmaceuticals Inc.

• 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 · 2023-03-17
  FDA Approved: GABAPENTIN — Supplemental Application (TIME CAP LABORATORIES, INC)

  FDA approved a supplemental application for gabapentin by Time Cap Laboratories, Inc., resulting in an approved update to the product's regu…

• FDA approval · 2023-02-17
  FDA Approved: QUTENZA — Supplemental Application (Averitas Pharma Inc)

  The FDA approved a supplemental application for QUTENZA (capsaicin) submitted by Averitas Pharma Inc. The document does not specify the exac…

• FDA approval · 2023-01-18
  FDA Approved: GABAPENTIN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's gabapentin in an Original Application, granting a generic version of gabapentin (ANDA 216492).

• 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 · 2022-07-18
  FDA Approved: PREGABALIN — Original Application (MARKSANS PHARMA LIMITED)

  FDA approved the original ANDA for pregabalin from Marksans Pharma Limited (ANDA216197).

• FDA approval · 2022-03-31
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin from Ascend Laboratories, LLC.

• FDA approval · 2022-03-22
  FDA Approved: PREGABALIN — Original Application (Advagen Pharma Ltd.)

  FDA approved Pregabalin under an Original Application for Advagen Pharma Ltd., authorizing the generic product.