Glenmark's US partner salix secures USFDA approval for crofelemer tablet

Crofelemer tablets are used in the treatment of diarrhoea in HIV patients.


New Delhi, January 2, 2013: Drug firm Glenmark Pharmaceuticals today said that the US health regulator, USFDA has granted marketing approval to its US partner Salix Pharmaceuticals for Crofelemer tablets used in the treatment of Diarrhoea in HIV-infected patients.


It is to be mentioned here that the approval is for the 125 mg delayed-release tablets. The company said in a statement that it is used for the symptomatic relief of non-infectious diarrhoea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy.


It is seen as a significant step in addressing the unmet medical need of people with HIV/AIDS on anti-retroviral therapy who experience non-infectious diarrhoea, which may often lead to reduced treatment compliance. The company also said that it is the sole API supplier globally for Crofelemer (ex-China).


Salix claims that close to 15 per cent of the 1.2 million HIV-positive/AIDS patients in the US suffer from chronic diarrhoea.


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