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    FDA Promises Easier Generic Drug Applications

     

    ANDAs for complex drugs may undergo more review cycles than other generic drugs, according to Gottlieb, who detailed other challenges for generic drugmakers. "These hurdles, in turn, may result in limited competition and higher prices,” he wrote. “We recognize these problems and are taking a number of new steps to support the development of high quality ANDAs for complex generic drugs.”

    FDA’s new draft guidance is meant to assist ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors looking to develop complex generic drugs.

    However, when the agency determines an application doesn’t meet approval standards, companies can learn a lot by discussing with the FDA ways in which they can come back with the information needed for the application, Gottlieb added.

    FDA also issued a draft guidance  to help applicants determine when submission of ANDAs for certain complex products that are peptides would be appropriate, Gottlieb wrote.

    The new guidance applies to ANDAs for certain specific synthetic peptides, namely, glucagon, liraglutide, nesiritide, teriparatide, and teduglutide, that reference brand-name versions manufactured using recombinant DNA technology.

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