New Delhi : 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.