Aurobindo gets final US FDA nod for Ondansetron injections

Moneycontrol Bureau

Aurobindo Pharma has received final apprpoval from US Food and Drugs Administration to manufacture and market Ondansetron Injection 2mg/ml strength packaged in 40mg/20ml multiple dose vials and 4mg/2ml single dose vials.

The approved Ondansetron injections are a generic version of GlaxoSmithKline Pharma's Zofran injection and indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or post-operative nauses and or vomiting.

These are the first abbreviated new drug applications approved out of the Unit IV formulation facility in Hyderabad for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by subsidiary AuroMedics Pharma LLC, Aurobindo said on Monday.

The company has invested close to Rs 280 crore on this plant and has filed for 18 ANDAs from this facility, according to Hitesh Mahida, analyst at Fortune Equity Brokers.

It now has 169 ANDA approvals, including 143 final approvals from the US FDA.

Aurobindo Pharma shares were up over 2 percent at Rs 196.50 on NSE in morning trade.

"The next important trigger for the stock now remains the resolution of Unit VI which used to generate close to USD 32 million before getting warning letter from USFDA and also manufactures injectibles," Mahinda said.

The analyst expects resolution of Unit VI issue in the near term, and he says both this facilities will allow Aurobindo to cash in on the injectable drugs shortage situation in the US and accordingly improve the overall margins.

Nachiket Kelkar
nachiket.kelkar@network18online.com