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PFIZER's CONTINUED ATTACK ON MARTEC NIFEDIPINE ANDAs

Executive Summary

PFIZER's CONTINUED ATTACK ON MARTEC NIFEDIPINE ANDAs is pursuing the question of bioequivalence requirements for single- ingredient generic approvals. Pfizer is renewing a citizen petition argument with FDA against Martec's pending ANDAs in spite of already approved generic versions of the product and Pfizer's own increased reliance on the follow-up generation of the product, Procardia XL. In an April 4 petition to FDA, Pfizer contends that a statement by Martec on bioequivalence in a patent litigation suit should be taken into consideration by FDA in its review of the generic firm's ANDAs and the ANDA suitability petitions. Martec's court statement that its nifedipine and the brandname product Procardia are not bioequivalent "directly contradicts Martec's statements to FDA" in its ANDA suitability petitions "and for that reason alone should be cause to rescind approval of the suitability petitions or deny approval of the ANDAs," Pfizer said. The petitions "represented that its products would achieve 'bioequivalence with the marketed soft gelatin capsules,'" Pfizer said. Pfizer is asking FDA to reconsider a March 7 denial of a previous petition against the Martec application. Pfizer maintains that "at the very least, FDA should view any bioequivalence studies in the Martec ANDAs with considerable skepticism and should demand a public explanation from Martec (such as through this citizen petition proceeding) before taking any action to approve the ANDAs." In denying the original petition, FDA stated: "The petitioner has not cited, nor can we find, any statutory provision that would require FDA to deny ANDA approval due to an ANDA applicant's court statements." The agency added that "the statute clearly states that the Secretary shall approve an ANDA unless 'information submitted in the application is insufficient to show that the drug . . . can be expected to have the same therapeutic effect as the listed drug.'" Pfizer argued that "nothing requires FDA to ignore information that it has obtained through other means." The company stated that "it is utterly inconsistent with the fraud policy, and with the sound protection of the public health, for FDA to ignore Martec's statements on the ground that it must blindly approve the ANDAs based solely on what is in the applications." Pfizer maintained that FDA's denial of its original petition was also based on the agency's proposition "that no showing of bioequivalence is required for approval of the Martec ANDAs." The firm stated that "the agency must require bioequivalence for approval of an ANDA for a single-ingredient drug filed pursuant to a suitability petition." In addition, "there is no other way, without clinical trials, to demonstrate that the generic drug will have the same therapeutic effect as the listed drug." FDA has pointed out to Pfizer that "the statute does not require bioequivalence information in an ANDA that is filed pursuant to an approved suitability petition. For such ANDAs, the statute calls only for information to show that the proposed drug's active ingredients 'are of the same pharmacological or therapeutic class as those of the listed drug' and that the drug 'can be expected to have the same therapeutic effect.'"
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PS019056

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