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Fulyzaq Approval History

  • FDA approved: Yes (First approved December 31st, 2012)
  • Brand name: Fulyzaq
  • Generic name: crofelemer
  • Dosage form: Delayed-Release Tablets
  • Company: Napo Pharmaceuticals, Inc.
  • Treatment for: Diarrhea

Fulyzaq (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.

Development History and FDA Approval Process for Fulyzaq

Dec 31, 2012Approval FDA Approves Fulyzaq - First Anti-Diarrheal Drug for HIV/AIDS Patients
Sep  5, 2012FDA Continues Review of Crofelemer New Drug Application beyond PDUFA Goal Date of September 5, 2012
May  3, 2012Napo Comments on FDA Announcing Extension of Crofelemer NDA Priority Review
Apr 30, 2012Salix Pharmaceuticals Announces Extension of Crofelemer NDA Priority Review
Feb  7, 2012Salix Pharmaceuticals Announces FDA Granting of Priority Review Designation for the Crofelemer NDA for Treatment of Diarrhea in Patients with HIV/AIDS on Anti-Retroviral Therapy
Dec 14, 2011Salix Pharmaceuticals Announces NDA Submission for Crofelemer for the Treatment of HIV-Associated Diarrhea

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