Complete Response Letters
Fidelity BioPharma Co.: Ontralfy
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 29, 2024
Food, Drug, and Cosmetic Act (FDCA), for Ontralfy (tizanidine) oral solution, 2 mg/5 mL.
CRL_NDA216190_20240329:p1:s11We also acknowledge receipt of your amendment dated March 7, 2024, which was not reviewed for this action.
CRL_NDA216190_20240329:p1:s12Agency's information request dated November 29, 2023. While we have not performed an in-depth review.
CRL_NDA216190_20240329:p1:s19% for which would result in a maximum daily intake |™mg) of at exceeds the qualification threshold, as recommended in uidance (ICH Q3B(R2), August 2006).
CRL_NDA216190_20240329:p1:s39(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA216190_20240329:p2:s19More Complete Response Letters
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