Mytesi 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 History and FDA Approval Process for Mytesi
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