Lupin gets USFDA nod for cevimeline hydrochloride capsules

The company has received final approval from the USFDA to market its cevimeline hydrochloride capsules 30 mg, Lupin said in a filing to BSE on 02 Jan.

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.

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Lupin gets CDSCO nod for indigestion treatment tablets

New Delhi, Aug 22: Drug firm Lupin has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Acotiamide 100 mg tablets used for treatment of indigestion.

It said the company will shortly start promoting the product in India.

"Acotiamide is a first-in-class novel drug to be introduced into the Indian pharmaceutical market which could benefit millions of patients suffering from dyspepsia or indigestion, amongst the most common stomach complaints encountered in clinical practice," Lupin said in a BSE filing.

Acotiamide is approved by Pharmaceuticals and Medical Devices Agency (PMDA) Japan and is actively marketed in Japan, it added.

Lupin President Naresh Gupta said: "I am sure that the approval of Acotiamide would go a long way in addressing an otherwise common but unmet medical need for a safe and effective drug for the management of dyspepsia."

Acotiamide is approved for the treatment of post meal fullness, bloating and early satiety in functional dyspepsia by the CDSCO (India), the company said.

Shares of Lupin were trading 1.67 per cent down at Rs 1,550.95 on BSE.

Published by: News

Source : ETHealthworld

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