Sjögren Syndrome

• FDA approval · 2026-03-11
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves cevimeline hydrochloride as an original ANDA submission from Zydus Lifesciences Limited.

• FDA approval · 2025-07-24
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cevimeline hydrochloride from Rising Pharma Holdings, Inc., confirming changes to the product's …

• FDA approval · 2024-09-20
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's cevimeline hydrochloride as an approved generic under ANDA206808.

• FDA approval · 2023-11-08
  FDA Approved: CEVIMELINE — Original Application (Bionpharma Inc)

  FDA approved an original ANDA for cevimeline hydrochloride (CEVIMELINE), a generic oral therapy from Bionpharma Inc, for the treatment of xe…

• FDA approval · 2023-04-18
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves cevimeline hydrochloride under the Original Application by Aurobindo Pharma Limited for treatment of Sjögren's syndrome.

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• FDA approval · 2023-04-06
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's cevimeline hydrochloride as an original application. It is indicated for the treatment of xerostomia in Sj…

• FDA approval · 2020-09-21
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's pilocarpine hydrochloride under an original generic application.

• FDA approval · 2016-12-30
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' cevimeline hydrochloride under an original application for the treatment of dry mouth due to Sjögren's s…

• FDA approval · 2015-09-10
  FDA Approved: SALAGEN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for SALAGEN (pilocarpine hydrochloride) filed by Advanz Pharma (US) Corp. The approval updates the p…

• FDA approval · 2014-06-04
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings' cevimeline hydrochloride as an Original Application (ANDA 203775), establishing a generic version of th…

• FDA approval · 2014-01-27
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for pilocarpine hydrochloride (Sandoz Inc) to update its labeling with additional indications.

• FDA approval · 2013-07-08
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved cevimeline hydrochloride (oral) as an original application generic product for the treatment of xerostomia associated with Sjög…

• FDA approval · 2007-02-27
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (AMICI PHARMACEUTICALS LLC)

  The FDA has approved a supplemental application for pilocarpine hydrochloride submitted by Amici Pharmaceuticals LLC, updating the product l…

• FDA approval · 2006-12-08
  FDA Approved: EVOXAC — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approves a supplemental application for EVOXAC (cevimeline hydrochloride) by Cosette Pharmaceuticals, Inc. The action provides supplemen…