Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

Fulvestrant injection 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.

New Delhi: Mumbai based Glenmark Pharmaceuticals recently received tentative approval from the United States Food & Drug Administration (USFDA) for Fulvestrant injection used for the treatment of advanced breast cancer in postmenopausal women.

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

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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.

Fulvestrant, sold under the brand name Faslodex among others, is a medication used to treat hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression as well as HR-positive, HER2-negative advanced breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

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

Glenmark Pharmaceuticals is headquartered in Mumbai. The company was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer.

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