The US Food and Drug Administration has given Zydus Lifesciences Ltd final approval to commercialise its generic version of Cyanocobalamin injectable, which is used to treat and prevent vitamin B12 deficiency caused by pernicious anaemia.
The US Food and Drug Administration (USFDA) has approved Cyanocobalamin injection in multiple-dose vials with strengths of 1,000 mcg/ml, 10,000 mcg/10 ml, and 30,000 mcg/30 ml, according to the business. "The medicine will be made at the group's injectables production facility in Jarod, Gujarat," the statement said.
Cyanocobalamin injection is used to treat and prevent vitamin B12 deficiency caused by pernicious anaemia (a lack of a natural substance required to absorb vitamin B12 from the intestine), certain diseases, infections, or medications that reduce the amount of vitamin B12 absorbed from food, the company said.
Since the beginning of the filing procedure in FY 2003-04, Zydus Lifesciences has received 331 approvals and filed over 400 abbreviated new medication applications, according to the company.
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