Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market amoxicillin for oral suspension.
Amoxicillin is the second largest selling antibiotic in the US after ciprofloxacin. Ranbaxy is the first generic company to get an approval amoxicillin for oral suspension as an alternative to the brand.
Based on bioequivalent studies, the formulation has been deemed to be bioequivalent and therapeutically equivalent to Amoxil for oral suspension 200 mg/5 ml and 400 mg/5 ml manufactured by GlaxoSmithKline.
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Amoxicillin is indicated in the treatment of infections of the ear, nose and throat, the genitourinary tract, the skin and skin structure, the lower respiratory tract, gonorrhea, acute uncomplicated (ano-genital and urethral) infections and H pylori eradication to reduce the risk of duodenal ulcer recurrence.
The total amoxicillin market is estimated to be $235.4 million with suspensions accounting for $104.1 million and the amoxicillin in both the 200 and 400 mg per 5 ml strengths total to around $63.4 million.
RPI has already received approvals for other forms of amoxicillin including amoxicillin 500mg and 875 mg tablets, 250 mg and 500 mg capsules, 125 mg and 250 mg chewable tablets.
With this new approval, RPI is positioned to offer multiple dosage forms of amoxicillin that includes capsules, tablets, chewable tablets, and suspensions in multiple strengths and package sizes.
By offering these additional strengths as a liquid, RPI will provide pharmacists with a cost effective, generic alternative that will meet the clinical needs of the patient/care giver and support the prescribing patterns of physicians.
This product was developed and will be manufactured at RLL in their dedicated facilities to support the market requirements for this product.
Sales and marketing for this product will be supported by the Ranbaxy Sales and Marketing Group and the product will be made available to all dispensing outlets located throughout the US, including chain pharmacies, wholesalers, and generic distributors, the release said.
The product will also be made available as soon as inventories are achieved to support market requirements.