Aurobindo Pharma gets USFDA nod for Azithromycin 250 mg and 500 mg
New Delhi: Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market Azithromycin tablets, used for the treatment of patients with mild to moderate infections, in the US market.
The approval has been granted in the strengths of 250 mg and 500 mg, and the product will be launched this month, Aurobindo Pharma said in a BSE filing.
Azithromycin is one of the most common antibiotic used for the treatment of a number of bacterial infections. Its usages includes middle ear infections, strep throat, pneumonia, traveler's diarrhea, and certain other intestinal infections.
The approved product is the generic equivalent of Pfizer Inc's Zithromax tablet, it added.
Quoting IQVIA sales data, the company said, the approved product has an estimated market size of USD 132 million for the 12 months ending May 2018.
Aurobindo Pharma currently has a total of 337 ANDA approvals (344 final approvals including 17 from Aurolife Pharma and 35 tentative approvals) from the US.
Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's area of activity includes six major therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterological, and anti-allergics. The company markets these products in over 125 countries. Its marketing partners include AstraZeneca and Pfizer.