Glenmark gets US health regulator nod for generic breast cancer injection

Drug firm Glenmark 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.

Glenmark 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, Glenmark said.

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Planning a baby? Here’s why you should watch your weight

Excess weight and obesityin pre-pregnancy period bring changes in breast milk that can impact infant growth, a study claims.

The study was published in the journal ‘PLOS ONE’.

“The importance of this study is that it demonstrates that breast milk contents can vary depending on mother’s weight status at the time of conception and further impact the growth and development of breastfeeding infants,” said Henry Nuss, lead author of the study.

“Childhood obesity rates in the United States have increased significantly in recent decades,” noted Melinda Sothern, professor of Behavioral & Community Health Sciences at Louisiana State University Health Sciences Center.

“Although many studies have shown that breastfeeding may be protective against excessive weight gain during early life, we do not fully understand why,” Sothern added.

Breast milk contains pro-inflammatory proteins such as tumour necrosis factor alpha (TNF-a) and interleukin-six (IL-6), as well as hormones like insulin and leptin, and anti-inflammatory polyunsaturated fatty acids, such as omega-3 (DHA) and omega-6 (EPA). If and how their interaction may influence infant growth has been unknown.

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