Wockhardt has been given United States FDA green signal for marketing an oral suspension of a combination of Amoxycillin and Clavulanate Potassium. Wockhardt's Chicago arm Morton Grove Pharmaceuticals received the approval for marketing a suspension containing 250 mg/ 5ml of Amoxycillin and 62.5mg/ 5ml of Clavulanate potassium, used for treating several common infections, especially in children.
The product is sold in the US by Glaxo SmithKline under the brand name Augmentin 250.
"Wockhardt is the first company to receive an ANDA approval for this strength of Augmentin" said Wockhardt Chairman Habil Khorakiwala. "Pediatric products are a major focus area for Morton Grove and this exclusive generic will be one of the several other unique pediatric products in our portfolio."
Wockhardt plans to launch this product in the US around the third quarter of 2009. The market for the 250/ 62.5 combination of Augmentin in the US is estimated at around $32 million.
The product was developed in collaboration with Cipla and will be exclusively manufactured and supplied for Wockhardt by Cipla from its FDA approved facility in Goa.
In the prescription generics market, Wockhardt has been on an expansion spree. Wockhardt today markets over 60 products in the US. Morton Grove Pharmaceuticals is one of the major players in the generics liquid products in the US and manufactures over 30 items at its facility near Chicago.
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