Glenmark gets USFDA nod for generic breast cancer injection


NEW DELHI, Aug 23: 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 USD 549.9 million, Glenmark 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.