Ranbaxy Laboratories Limited announced that the company has received tentative approval from the Office of Generic Drugs of the US FDA to manufacture and market Amoxicillin and Clavulanate potassium tablets USP (chewable), 200 mg/28.5 mg (base) and 400 mg/57 mg (base).

The Division of Bioequivalence has determined Ranbaxy’s Amoxicillin and Clavulanate potassium tablets USP (chewable), 200 mg/28.5 mg (base) and 400 mg/57 mg (base), to be bioequivalent and, therefore, therapeutically equivalent to the listed drug (Augmentin chewable tablets, 200 mg and Augmentin chewable tablets, 400 mg, respectively of GlaxoSmithKline). Total market sales for all forms of Amoxicillin and Clavulanate potassium chewable tablets were $31.4 million.

Augmentin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in conditions such as lower respiratory tract infections, otitis media, sinusitis, skin and skin structure infections and urinary tract infections. While Augmentin is indicated only for the situations listed above, infections caused by ampicillin-susceptible organisms are also amenable to Augmentin treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and (beta)-lactamase-producing organisms susceptible to Augmentin should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against Streptococcus pneumoniae than does ampicillin or penicillin, the majority of S pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and Augmentin.

Commenting on the approval, Jim Meehan, vice president, Sales and Marketing, Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy, said, “Amoxicillin and Clavulanate potassium chewable tablets will be made available nationwide through retail pharmacies, wholesalers and distributors as quickly as inventories can be reached to support the needs of the US Healthcare system. We now offer a complete line of formulations for this anti-infective agent that will meet the needs of patients and prescribers at an affordable price.”

Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the US in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, US operations achieved sales of US $296 mn, a growth of 162 per cent over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the US generics market.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and active pharmaceutical ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in new drug discovery research. Ranbaxy's foray into novel drug delivery systems has led to proprietary "platform technologies" resulting in a number of products under development. The company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 34 countries and manufacturing operations in 7 countries.