Wockhardt's Chicago-based subsidiary Morton Grove Pharmaceuticals has received US FDA approval for marketing an oral suspension of a combination containing 250mg/5ml of amoxicillin and 62.5mg/5ml of clavulanate potassium. This combination is used for treating several common infections, especially in children. Currently, GlaxoSmithKline is selling this product in US under the brand name Augmentin 250.
Habil Khorakiwala, chairman of the company, said, "Wockhardt is the first company to receive an ANDA approval for this strength of Augmentin. Paediatric products are a major focus area for Morton Grove and this exclusive generic will be one of the several other unique paediatric products in our portfolio."
The company intends to launch this product in the US sometime in Q3 of 2009. According to IMS, the market for the 250/62.5 combination of Augmentin in the US is about $ 32 million.
The product was developed as a part of a series of collaborative projects along with Cipla Ltd. The product will be exclusively manufactured and supplied for Wockhardt by Cipla from its FDA approved facility in Goa.