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BIOCRAFT LIQUID IBUPROFEN IS NOT ANDAable: COMPARISON TO TABLETS

Executive Summary

BIOCRAFT LIQUID IBUPROFEN IS NOT ANDAable: COMPARISON TO TABLETS will not suffice, FDA says in a letter denying the company permission to pursue the ANDA route to market the product. Biocraft had sought to clear its ibuprofen oral liquid 200 mg/5 ml for OTC use, referencing Whitehall's 200 mg Advil tabs, and 400 mg/10 ml for prescription use only by referencing Upjohn's 400 mg Motrin. "The Agency would not consider a liquid ibuprofen as safe as the approved tablets unless the labeling were adequate to prevent use in children," the letter states. Biocraft stated in its petition that, as with the approved ibuprofen forms, pediatric use would not be recommended for its liquid ibuprofen product. However, FDA pointed out that "liquids are most often used in the pediatric population, [and] in the elderly." The agency commented that even "warnings against pediatric use in the listed product's labeling would not be sufficient to prevent unsafe use of the proposed product in children." Biocraft initially submitted a petition for the 200 mg/5 ml product in May, indicating that it would not be seeking pediatric use. The firm did cite 41 clinical studies demonstrating safety and efficacy of ibuprofen use in children. Following a less than favorable reaction from FDA, Biocraft resubmitted the petition in August without reference to pediatric studies for two strengths - the 200 mg/5 ml for OTC and the 400 mg/10 ml for prescription use. FDA cited the absence of studies on the safety and effectiveness of liquid ibuprofen, especially in children, as the major reason for denial of the petition, and emphasized "that investigations must be conducted to show the safety or effectiveness of a proposed drug product or any of its ... dosage forms, ... which differ from the listed drug." Pointing out that since "the proposed change in dosage form would increase the risk of unsafe use of the product," FDA states that, "at a minimum, the addition of significant new labeled warnings" would be required. The agency noted that it has "no evidence that the new warnings are likely to make the generic product as safe as the listed drug."
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