Generics
Amneal passes US FDA's approval for Cyclophosphamide for Injection USP
31 May 2018 -

Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide for Injection USP.

The company said the Cyclophosphamide for Injection USP is the AP-rated therapeutic equivalent to Cytoxan in 500 mg, 1 g and 2 g Single-Dose Vials.

In conjunction with the US FDA approval, the company expects to begin shipment of Cyclophosphamide for Injection USP shortly.

For the 12 months ending April 2018, the Cyclophosphamide for Injection USP in 500 mg, 1 g and 2 g had annual US generic sales of about USD332m according to IQVIA. The drug is used for treating malignant lymphomas, multiple myeloma, carcinoma of the breast, among others.

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