Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a specialty pharmaceutical company, today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Cyclophosphamide for Injection USP, the Company’s AP-rated therapeutic equivalent to Cytoxan® 500 mg, 1 g and 2 g Single-Dose Vials. The Company expects to begin shipping product shortly.
“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.”
Cyclophosphamide for Injection USP, 500 mg, 1 g and 2 g had annual U.S. generic sales of approximately $332 million according to IQVIA™ for the 12 months ending April 2018.
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