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Glenmark gets tentative USFDA nod for generic advanced breast cancer injection

Press Trust of India  |  New Delhi 

Drug firm Pharmaceuticals Thursday said it has received tentative approval from the US health regulator for generic injection used for in postmenopausal women.

Pharmaceuticals Inc, USA, has been granted tentative approval by the Food & Drug Administration (USFDA) for injection, 250 mg/5 mL (50 mg/mL), the company said.

The product is a generic version of 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, 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

The injection is used for treatment of hormone receptor positive, human epidermal growth factor receptor 2 - negative in postmenopausal women.

Shares of Glenmark Pharmaceuticals closed down 0.33 per cent at Rs 638.65 on BSE.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, February 07 2019. 16:15 IST