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Glenmark gets US health regulator nod for generic breast cancer injection

The product is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex Injection in the same strength, the company said

Glenmark | USFDA | Pharma sector

Press Trust of India  |  New Delhi 


Drug firm Pharmaceuticals on Friday said its US arm has received the final approval from the US health regulator for its Fulvestrant injection used for the treatment of advanced breast cancer.

The product is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex Injection in the same strength, the company said in a statement.

Pharmaceuticals Inc USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Fulvestrant injection in the strength of 250 mg/5 mL (50 mg/mL), it said.

According to IQVIA sales data for the 12-month period ending June 2019, the Faslodex injection, 250 mg/5 mL (50 mg/mL) brand and and all available therapeutic equivalents achieved annual sales of approximately $549.9 million, said.

The company's current portfolio consists of 159 products authorised for distribution in the US marketplace and 56 abbreviated new drug applications (ANDA's) pending approval with the USFDA, it added.

Shares of Glenmark Pharmaceuticals were trading at Rs 360.95 on BSE, up 0.39 per cent from the previous close.

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First Published: Fri, August 23 2019. 10:45 IST