Aurobindo gets USFDA nod to market generic anti-infective drug

Image
Press Trust of India New Delhi
Last Updated : Sep 16 2014 | 4:56 PM IST
Aurobindo Pharma has received approval from the US health regulator to market generic version of Amoxicillin for oral suspension, used to treat infections, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Amoxicillin for Oral Suspension USP, the Hyderabad-based firm said in a statement.
Amoxicillin for Oral Suspension is the generic equivalent to the Teva Pharmaceutical Industries' product and indicated in the treatment of infections, it added.
According to IMS sales data, the product has a market size of around USD 19 million for the 12 months ended July 2014.
"This abbreviated new drug application (ANDA) has been approved out of Unit XII, semi-synthetic penicillin (SSP) formulation facility in Hyderabad," the company said.
Aurobindo now has a total of 195 ANDA approvals from the USFDA.
Shares of Aurobindo Pharma today closed at Rs 854.30 apiece on the BSE, down 4.25 per cent from the previous close.
*Subscribe to Business Standard digital and get complimentary access to The New York Times

Smart Quarterly

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Exclusive premium stories online

  • Over 30 premium stories daily, handpicked by our editors

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Sep 16 2014 | 4:56 PM IST

Next Story