Drug firm Glenmark Pharmaceuticals Thursday said it has received tentative approval from the US health regulator for generic Fulvestrant injection used for treatment of advanced breast cancer in postmenopausal women.
Glenmark Pharmaceuticals Inc, USA, has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Fulvestrant injection, 250 mg/5 mL (50 mg/mL), the company said.
The product is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added.
The Faslodex injection 250 mg/5 mL (50 mg/mL) brand and all available therapeutic equivalents achieved annual sales of around USD 533.3 million, Glenmark said.
The company's current portfolio consists of 148 products authorised for distribution in the US market and 54 abbreviated new drug applications (ANDA's) pending approval with the USFDA.
The injection is used for treatment of hormone receptor positive, human epidermal growth factor receptor 2 - negative advanced breast cancer in postmenopausal women.
Shares of Glenmark Pharmaceuticals closed down 0.33 per cent at Rs 638.65 on BSE.
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