Aurobindo Pharma receives US FDA approval for Acetylcysteine injection

By: |
March 01, 2016 2:08 PM

The product is likely to be launched in Q1 FY16-17

The product is likely to be launched in Q1 FY16-17

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Acetylcysteine injection, 6g/30 mL (200 mg/mL) single-dose vials. The product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Acetadote injection, 6 g/30 mL, of Cumberland Pharmaceuticals.

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 approved product has an estimated market size of $28 million for the 12 months ending December 2015 according to IMS.

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 and 35 Tentative approvals) from US FDA.

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