Sandoz announces FDA approval, U.S. launch of chemotherapy drug

Docetaxel is drug maker's 11th cancer drug launch in U.S.

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

The drug is a ready-to-use formulation of Sanofi's Taxotere in a single vial.* Various versions of Taxotere had sales of about $1.1 billion during the 12-month period ended in June, according to IMS Health. The drug is used to treat cancers of the lung, breast, prostate, stomach, head and neck, in combination with various other drugs.

* CORRECTION: An earlier version of this story referred to the drug as a generic version of Taxotere, based on an error in Sandoz's original press release. The drug was approved under an FDA New Drug Application, as opposed to an Abbreviated New Drug Application, as is the case with generic drugs, so Sandoz's product is not technically a generic drug.

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