The company has received US FDA final approval for its ANDA for Docetaxel Injection USP in the strengths of 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL)
Shilpa Medicare announced that it has received final approval from the US health regulator, US FDA, for Docetaxel Injection, used for treatment of various types of cancers.
The company has received US Food and Drug Administration final approval for its abbreviated new drug application (ANDA) Docetaxel Injection USP in the strengths of 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL), Shilpa Medicare said in a Bombay Stock Exchange (BSE) filing.
Docetaxel Injection USP is a generic equivalent of reference listed drug (RLD) Taxotere used in the treatment of breast cancer, non-small cell lung cancer, prostate cancer, castric adenocarcinoma, head and neck cancer as recommended in the label approved by USFDA.
Quoting IQVIA MAT first quarter 2019 data, the company said the US market for Docetaxel Injection USP is approximately USD 32.13 million.
Shares of Shilpa Medicare were trading 3.01 per cent up at Rs 384.90 apiece on the BSE.