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Pharmaceuticals / Regulatory Affairs

FDA Denies Amneal Petition to Reject ANDAs for Generic Forteo

Jan. 12, 2018

The FDA rejected a request from Amneal not to approve ANDAs for generics of its osteoporosis drug Forteo.

In the petition, Amneal wrote that a synthetic version of its drug could not satisfy the labeling requirements for ANDAs. In addition, it wrote, it is “virtually impossible” to predict immunogenicity of synthetic versions due to the numerous possible differences between the two.

The FDA rejected the petition on the same grounds as its response earlier in the week to a petition from Novo Nordisk, noting it has issued proposed guidance on ANDAs for certain highly purified synthetic peptide products.

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