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Jaguar Health announced its subsidiary, Napo Pharmaceuticals, filed a Chemistry, Manufacturing, and Controls supplement with the FDA for six-tablet bottles of Mytesi.
Jaguar Health (NASDAQ:JAGX) announced its subsidiary, Napo Pharmaceuticals, filed a Chemistry, Manufacturing, and Controls (CMC) supplement with the US Food and Drug Administration (FDA) for six-tablet bottles of Mytesi.
As quoted in the press release:
Napo’s FDA-approved human drug, in preparation for Napo’s planned national sample campaign.
Mytesi is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar and Napo are pursuing a follow-on indication for Mytesi in chemotherapy-induced diarrhea (CID), an important supportive care indication for patients undergoing primary or adjuvant chemotherapy for cancer treatment.
The planned sample bottles will contain enough Mytesi tablets for three days of use. To implement the filing, Napo produced stability data in support of a one-year shelf life for the contents of the sample bottles.
Click here to read the full press release.
Source: www.businesswire.com
