FDA approves Amneal’s generic Cytoxan

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FDA approves Amneal’s generic Cytoxan

By David Salazar - 05/30/2018
The Food and Drug Administration has approved Amneal’s generic Cytoxan (cyclophosphamide for injection). The drug is indicated to treat certain types of cancers, including breast cancer, ovarian cancer and acute myeloid leukemia, among others.

“This is an important milestone as Amneal continues to focus on enhancing its portfolio of complex injectable products and bringing these important medications to patients and healthcare providers,” said Rob Stewart, president and CEO of Amneal. “Our diversified pipeline of more than 145 filed ANDAs provides numerous opportunities to drive growth in 2018 and beyond.”

Amneal’s generic Cytoxan will be available in 500-mg, 1-g and 2-g single-dose vials. The drug had an approximate market size of $332 million in generic sales for the 12 months ended April 2018. Amneal said it expects to begin shipping the Cytoxan generic shortly.


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