US FDA GIVES APPROVAL TO ZYDUS CADILA FOR SELLING DRUGS FOR HIV

Highlights
• The Ahmedabad-based drugmaker said it has received final approval from the US-based drug regulator to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets


According to a statement issued by Indian pharmaceutical company Zydus Cadila on Friday, it has been granted an approval by the United States Food and Drug Administration to sell generic Emtricitabine and Tenofovir Disoproxil Fumarate tablets.


The Ahmedabad-based drugmaker said it has received final approval from the US-based drug regulator to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg, a combination used in the treatment of HIV infection which causes AIDS.


Zydus Cadila said in the statement that the drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.


It further said this new drug is used with other HIV medications to help curb HIV infection and also aids in bringing down the amount of the virus in the body of the infected person which ultimately results in better functioning of the immune system.


With this approval, the Indian pharma group has 319 approvals and has filed more than 400 abbreviated new drug applications (ANDAs) said the company.

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