Wednesday, 24 April 2019

Glenmark receives tentative ANDA approval for Fulvestrant

07 February 2019 | News

It is a generic version of FASLODEX Injection

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

Glenmark’s current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the U.S. FDA.

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