New Delhi: 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,” Aurobindo Pharma said in a BSE filing.
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,” the company said.
Quoting IMS data, Aurobindo Pharma said the approved product has an estimated market size of USD 28 million for the twelve months ended December 2015.
This is the 26th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, used for manufacturing general injectable products.
Aurobindo now has a total of 242 ANDA approvals (207 Final approvals including 10 from Aurolife Pharma LLC and 35 Tentative approvals) from USFDA.