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Mytesi FDA Approval History

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

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

Mytesi (crofelemer) was first approved as Fulyzaq in December 2012.

In October 2016, Napo Pharmaceuticals, Inc. announced the launch and general availability of the new brand Mytesi (crofelemer).

Development timeline for Mytesi

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

Further information

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