NEW DELHI, Jan 2: Drug firm Lupin has received final approval from the US health regulator to market cevimeline hydrochloride capsules, used for treatment of symptoms of dry mouth in patients with Sjogren’s syndrome, in the US market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market its cevimeline hydrochloride capsules 30 mg, Lupin said in a filing to BSE today.
The company’s product is a generic version of Daiichi Sankyo Inc’s Evoxac capsules, it added.
The company further said that it will commence promoting the product immediately. Evoxac capsules had US sales of USD 40.8 million as per IMS MAT September 2016 data, it added.