Generics
Amerigen wins US FDA final approval for Abbreviated New Drug Application for cyclophosphamide capsules to treat cancers
21 March 2018 -

Generic pharmaceutical company Amerigen Pharmaceuticals Limited revealed on Tuesday the receipt of final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for cyclophosphamide capsules in 25mg and 50mg.

According to the company, its cyclophosphamide capsule ANDA is the first to be approved as a generic equivalent to West-Ward Pharmaceuticals' corresponding US reference listed drug. Cyclophosphamide is an anti-neoplastic agent used in the treatment of various cancers.

The company stated that its generic cyclophosphamide capsules are manufactured by Stason Pharmaceuticals Inc in Irvine, CA.

In conjunction with the US FDA approval, the company's US affiliate, Amerigen Pharmaceuticals Inc expects to launch the generic cyclophosphamide capsules in the near future.

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