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Zydus' erectile dysfunction drug, Tadalafil gets US FDA marketing nod

Our Bureau, Mumbai
Thursday, November 23, 2017, 14:45 Hrs  [IST]

Zydus Cadila has received the tentative approval from the US FDA to market Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg. The drug is indicated for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

The group now has more than 170 approvals and has so far filed over 310 ANDAs since the commencement of the filing process in FY 2003-04.

 

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pradeep Awasthi Nov 23, 2017 7:14 PM
Erectile dysfunction is the commonest condition manifested by many patients and normal subjects after fifties,it is equally common in western countries.It leads to depression,dementia or sleep disturbances.

The recently USFDA approved tadalafil which is used for treatment of erectile dysfunction could be a novel approach for treating this condition,but still its clinical safety trials are not conducted.


 
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