Drug major Aurobindo Pharma announced Tuesday in a corporate filing to BSE that it had received the final approval from the US Food and Drug Administration for an intravenous antidote to a painkiller drug overdose.
The approved acetylcysteine injection is expected to be launched in the first quarter of FY16-17, in 6g/30 ml (200 mg/ml) single-dose vials.
According to the Centers for Disease Control and Prevention (CDC), more than 16,000 people died in the U.S. in 2013 after taking prescription painkillers, quadrupling the number of deaths since 1999.
Quoting IMS, a global information and technology services company, Aurobindo Pharma said the approved product has an estimated market size of US$28 million for the 12 months ending December 2015.
The approved abbreviated new drug application (ANDA) is equivalent to Acetadote injection, 6g/30 ml, of Cumberland Pharmaceuticals, Inc., indicated to prevent or lessen hepatic injury after the patient ingests a potentially hepatotoxic quantity of acetaminophen.
This is the 26th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India, used for manufacturing general injectable products. Aurobindo pharma now has a total of 242 ANDA approvals (207 Final approvals including 10 from Aurolife Pharma LLC and 35 Tentative approvals) from USFDA.
On Tuesday, the shares of Aurobindo Pharma closed at the BSE at Rs 679.75 down Rs 5.75 or 0.76 percent.