Diabetic Neuropathy

• FDA approval · 2026-02-02
  FDA Approved: PREGABALIN — Supplemental Application (Tris Pharma Inc)

  FDA approves Tris Pharma Inc's supplemental application for pregabalin.

• EMA approval · 2025-10-15
  EMA Authorised: Duloxetine Viatris (previously Duloxetine Mylan) (duloxetine) — Viatris Limited

  The European Medicines Agency authorised a duloxetine product marketed as Duloxetine Viatris by Viatris Limited for several indications incl…

• FDA approval · 2025-04-30
  FDA Approved: PREGABALIN — Supplemental Application (Cipla USA, Inc.)

  The FDA approved Cipla's supplemental application to market a generic pregabalin product, enabling a generic version of the drug for its app…

• 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.,…

• EMA approval · 2024-11-29
  EMA Authorised: Duloxetine Zentiva (duloxetine) — Zentiva, k.s.

  The EMA authorised Duloxetine Zentiva (duloxetine) from Zentiva, k.s. as an approved medicinal product for neuralgia/diabetic neuropathy, ma…

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• 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…

• EMA approval · 2024-07-09
  EMA Authorised: Cymbalta (duloxetine) — Eli Lilly Nederland B.V.

  Cymbalta (duloxetine) has been authorized by the EMA for anxiety disorders, diabetic neuropathy, and major depressive disorder with Eli Lill…

• EMA approval · 2024-07-09
  EMA Authorised: Duloxetine Lilly (duloxetine) — Eli Lilly Nederland B.V.

  The European Medicines Agency authorised duloxetine (Lilly) by Eli Lilly Nederland B.V. for neuralgia, diabetic neuropathies, and major depr…

• 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 · 2023-07-12
  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 · 2020-09-29
  FDA Approved: GABAPENTIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gabapentin from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2020-04-03
  FDA Approved: LYRICA CR — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental NDA for LYRICA CR (pregabalin) submitted by Viatris Specialty LLC, indicating a regulatory approval of a supplem…

• FDA approval · 2019-05-23
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Div of Pfizer Inc, indicating an approved modificat…

• FDA approval · 2014-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for gabapentin (generic anticonvulsant) under the approved ANDA.

• FDA approval · 2011-04-26
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) filed by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC. This entry reflects a supplemental approval of a gen…