Lupin Limited yesterday announced that it has received final approval from the US Food and Drug Administration (FDA) to market its cevimeline hydrochloride capsule (30 mg). Lupin is expected to commence promoting the product shortly.
Cevimeline hydrochloride capsule (30 mg) is a generic version of Daiichi Sankyo Inc’s Evoxac capsule, which is indicated for the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome. Evoxac capsule had US sales of $ 40.8 million, according to IMS MAT September 2016.