Complete Response Letters
RB Health (US) LLC: naproxen sodium
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jul 26, 2024
Sinus and Cold (naproxen sodium 220 mg; pseudoephedrine HCI 120 mg extendedrelease tablet [NDA 021076]) were based on data retrieved from FDA reviews, which are not considered an appropriate source of information to rely on for approval from a regulatory perspective.
CRL_NDA217338_20240726:p1:s28Therefore, we conclude that the submitted material do not provide substantial evidence of efficacy to support the proposed 12-hour duration of action and dosing regimen.
CRL_NDA217338_20240726:p1:s30(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA217338_20240726:p2:s21More Complete Response Letters
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