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| Exchange Received Time 25/02/2019 09:24:28 Exchange Disseminated Time 25/02/2019 09:24:33 Time Taken 00:00:05 | This is to inform you that the Company has received U.S Food and Drug Administration approval for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial.
Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by FDA.'
According to IQVIA MAT 12/2018, the US market for Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial is approximately US$ 11.7 Million.
This is for your information and doing the needful.
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