Zydus Cadila gets USFDA nod for Hepatitis B drug

Zydus Cadila has received the final approval from the the US Food and Drug Administration to market Hepatitis B drug Entecavir.

The drug has sales of $166.3 million in the US, and will be sold in 0.5 mg and 1 mg dosage.

It will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad, it said.

With this, the group now has more than 120 approvals and has so far filed over 300 abbreviated drug applications since the commencement of the filing process in FY 2003-04.

The drug is sold under the brand name of Baraclude in the US and is manufactured by Bristol-Myers Squibb.

Hepatitis B is not the usual ‘jaundice’ found in tropical countries like India, which is caused by unclean surroundings.

The B variant, while also exhibiting similar symptoms including jaundice, is passed on via blood contact — such as through the use of infected needles, blood transfusion and sex.

Those who get it at birth tend to develop chronic hepatitis B, while those who get infected after five tend to be cured fully.

Most of those with chronic disease have no symptoms; however, cirrhosis and liver cancer may eventually develop, resulting in the death of 15 to 25% of those with chronic disease.