The company has received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today 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 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.
Lupin shares today settled at Rs. 1,841.15 on BSE, up 1.98 per cent from the previous close.