FDAnews Drug Daily Bulletin

Millennium Petitions FDA to Hold Off on Approvals of Generic Velcade

June 29, 2017

Takeda subsidiary Millennium Pharmaceuticals called on the FDA to withhold approval for generic versions of its drug Velcade (bortezomib) until at least next February, when a relevant exclusivity period expires.

Velcade holds exclusive rights to an indication for treatment of mantle cell lymphoma, but there is a potential safety risk if generics market their bortezomib products without this indication in the labeling, Millennium says in a citizen’s petition to the agency.

The FDA also should deny any applications from bortezomib products with multiple myeloma indications if their labeling does not address key safety issues, Millennium says. The bortezomib used in Velcade is in mannitol ester form before reconstitution, but numerous firms are developing generics that don’t contain mannitol ester. For example, Fresenius submitted an NDA substituting boric acid, among other ingredients, which presents a potential safety hazard and warrants an investigation, according to the petition.

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