Lupin gets FDA approval for generic Femhrt tablets

NEW DELHI: Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market.

The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin on Monday said in a statement.

"Lupin's US subsidiary, Lupin Pharmaceuticals Inc shall commence promoting the product in the US shortly," it added.

The company's product is the generic equivalent of Warner Chilcott's Femhrt tablets, which are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and prevention of postmenopausal osteoporosis.

According to IMS MAT September data, Femhrt had US sales of $39.9 million.

The Mumbai-based firm has launched eight products in the US this fiscal and received approvals for 19 from the FDA.

The company's cumulative abbreviated new drug application (ANDA) filings with the USFDA stood at over 220 with the company having received 131 approvals to date.