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Aurobindo gets FDA nod for antidote drug
City-based Aurobindo Pharma has received final approval from the US health regulator for generic version of an intravenous antidote to a pain-killer drug overdose. An antidote is a substance which can counteract a form of poisoning.
Hyderabad: City-based Aurobindo Pharma has received final approval from the US health regulator for generic version of an intravenous antidote to a pain-killer drug overdose. An antidote is a substance which can counteract a form of poisoning.
"The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetylcysteine Injection, 6g/30 mL (200 mg/mL) single-dose vials," the pharma major said in a release.
The product is expected to be launched in the first quarter of the next fiscal. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Acetadote Injection, 6 g/30 mL, of Cumberland Pharmaceuticals, Inc.
Acetylcysteine Injection is an antidote for acetaminophen (non-aspirin pain-reliever or analgesic) overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially-hepatotoxic quantity of acetaminophen, it added. The approved product has an estimated market size of $28 million for the twelve months ended December 2015, according to IMS data.
