Glenmark Pharmaceuticals receives tentative ANDA approval for Fulvestrant Injection

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of FASLODEX1 Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

According to IQVIATM sales data for the 12 month period ending December 2018, the FASLODEX Injection, 250 mg/5 mL (50 mg/mL) market2 achieved annual sales of approximately $533.3 million.

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