Postherpetic Neuralgia

• FDA approval · 2025-04-25
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for HORIZANT (gabapentin enacarbil) submitted by Azurity Pharmaceuticals. The approval updates t…

• FDA approval · 2025-03-13
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals' supplemental application for gabapentin to add a granule formulation.

• 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 · 2024-12-31
  FDA Approved: GABAPENTIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for gabapentin by ScieGen Pharmaceuticals, Inc.

• FDA approval · 2024-12-27
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc. The snippet does not specify the exact scope (e.g.,…

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• FDA approval · 2024-12-23
  FDA Approved: PREGABALIN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for pregabalin filed by Chartwell RX, LLC (ANDA212865).

• 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 · 2024-12-10
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC to modify an existing gabapentin product.

• FDA approval · 2024-12-02
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc., authorizing a modification to the approved …

• FDA approval · 2024-10-15
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for gabapentin filed by Aurobindo Pharma Limited. This action approves a generic formulation of …

• FDA approval · 2024-09-09
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc. The approval indicates a modification to the dr…

• 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 · 2024-07-31
  FDA Approved: QUTENZA — Supplemental Application (Averitas Pharma Inc)

  The FDA approved a supplemental application for QUTENZA (capsaicin patch) from Averitas Pharma Inc. The approval covers changes described in…

• FDA approval · 2024-07-12
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Neurontin (gabapentin) submitted by Parke-Davis Div of Pfizer Inc.

• 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 · 2024-05-29
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC under ANDA202024.

• FDA approval · 2024-04-08
  FDA Approved: GABAPENTIN — Original Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's Original Application for gabapentin, permitting the marketing of a generic gabapentin product.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approval of Gabapentin in an original application for Camber Pharmaceuticals, establishing a generic version of Gabapentin.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Epic Pharma, LLC)

  FDA approved the original application for gabapentin from Epic Pharma, LLC, introducing a generic gabapentin product to the market.

• FDA approval · 2024-02-20
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc., authorizing changes to the approved generic produc…

• FDA approval · 2024-01-24
  FDA Approved: GABAPENTIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the Gabapentin original ANDA from Zydus Pharmaceuticals USA Inc.

• 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 · 2024-01-17
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for gabapentin, a generic version of the anticonvulsant used for partial seizures …

• 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.