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usfda: Alembic Pharma gets USFDA nod to market generic cancer drug

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market a generic breast cancer drug. The company has received approval from the US Food & Drug Administration (USFDA) to market Docetaxel Injection in multiple dose vials, the drug maker said in a statement.

The company’s approved product is therapeutically equivalent to Hospira Inc’s drug.

Docetaxel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.

According to IQVIA data, Docetaxel injection has an estimated market size of USD 11 million in the US market.

Shares of the company were trading 0.72 per cent down at Rs 506.40 apiece on the BSE.

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