US FDA nod for Zydus Cadila's Acyclovir

August 31, 2014 | Sunday | Regulatory | By BioSpectrum Bureau

This is the second FDA approval that the company has received this month

This is the second FDA approval that the company has received this month

Singapore: The highest regulatory body has approved Zydus Cadila's anti-viral drug, Acyclovir. The company can now go ahead with the marketing of the drug.

"Zydus Cadila has received the final approval from the US FDA to market Acyclovir tablets. The drug falls under the anti-viral segment," the company said in a statement.

The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, the company further said. As per IMS, the estimated sales for these tablets in 2014 is $55.8 million.

This is the second FDA approval that the company has received this month. Earlier this month, its kidney stones drug, Potassium Citrate tablets were approved by the regulator.

The company has a total 95 approvals and has so far filed 249 ANDAs.

 

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