Shilpa Medicare receives USFDA approval for Busulfan Injection

Shilpa Medicare has received US Food and Drug Administration approval for its ANDA, Busulfan Injection, 60 mg/10 mL on 18 April 2019. Busulfan Injection, 60 mg/lO mL is a generic equivalent of reference listed drug (RLD), Busulfex Injection, 60 mg/10 mL, used in the treatment of patients with chronic myelogenous leukemia as recommended in the label approved by FDA.

According to IQVIA MAT Q4 2018 data, the US market for Busulfan Injection,6O mg/1O mL is approximately US$ 32.8 Million.

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