Aurobindo Pharma gets USFDA nod to launch antibiotic Cefixime
Th antibiotic had estimated sales of $123 million for the 12 months ended February in the US
Hyderabad: Aurobindo Pharma Ltd on Wednesday said it has been allowed to sell a generic antibiotic drug in the US.
The antibiotic Cefixime to treat infections had estimated sales of $123 million for the 12 months ended February in the US, the company said in a press release, citing IMS Health, a US based healthcare information provider.
Aurobindo Pharma said the US Food and Drug Administration (USFDA) has permitted it to manufacture and sell the drug for oral suspension under 100mg/5ml and 200mg/5ml dosage forms.
“The product is ready for launch," Aurobindo said in a release.
The approved abbreviated new drug application is equivalent to the branded generic Suprax of Lupin Pharmaceuticals Inc.
Wyeth Pharmaceuticals Inc., now owned by Pfizer Inc., discontinued selling Suprax in 2002, after the drug’s patent expired.
Cefixime, a third generation cephalosporin, is used for the treatment of adults and pediatric patients six months of age or older, with infections caused by susceptible strains of the designated organisms in urinary tract infections, otitis media, acute exacerbations of chronic bronchitis, uncomplicated gonorrhea (cervical/urethral), pharyngitis and tonsillitis.
Shares of Aurobindo gained 2.13% and were trading ₹ 1359 at 3.25pm on BSE, while the benchmark Sensex fell 0.84% to 28,800.11 points.
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