Pharmaceutical and biotechnology major Wockhardt received USFDA approval for marketing and oral suspension of a combination of Amoxycillin and Clavulanate Potassium.
The company’s Chicago-based subsidiary Morton Grove Pharamaceuticals received approval for marketing the suspension containing 250 mg/ 5ml of Amoxycillin and 62.5mg/ 5ml of Clavulanate Potassium, which is used for treating several common infections, especially in achildren. The product is sold in the US by Glaxo SmithKline under the brand name Augmentin 250.
Wockhardt intends to launch this product in the US sometimes in third quarter 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. The product will be exclusively manufactured and supplied for Wockhardt by Cipla from its FDA approved facility in Goa.
“Wockhardt is the first company to receive an Abbreviated New Drug Application approval for this strength of Augmentin,” said Wockhardt Chairman Habil Khorakiwala.
