Zydus Lifesciences receives final approval from US FDA for Cyanocobalamin injection

Zydus Lifesciences has received final approval from the US Food and Drug Administrration (FDA) to market Cyanocobalamin injection in the strengths of 1,000 mcg/mL,10,000 mcg/10 mL (1,000 mcg/mL), and 30,000 mcg/30 mL (1,000 mcg/mL) multiple-dose vials, a company statement said.

It notified that Cyanocobalamin injection is used to treat and prevent lack of vitamin B12 that may be caused due to pernicious anaemia (lack of a natural substance needed to absorb vitamin B12 from the intestine), certain diseases, infections or medications decrease the amount of vitamin B12 absorbed from food.

The drug will be manufactured at the group’s injectables manufacturing facility at Jarod, Gujarat, the statement added.