Wockhardt receives USFDA approval for generic version of Augmentin suspension
Wockhardt has received USFDA approval for marketing an oral suspension of a combination of amoxycillin and clavulanate potassium. Wockhardt's Chicago-based subsidiary Morton Grove Pharmaceuticals received approval from the USFDA for marketing the suspension containing 250 mg/5 ml of amoxycillin and 62.5 mg/5 ml of clavulanate potassium, which is 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. 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," said Habil Khorakiwala, chairman, Wockhardt.
Wockhardt intends to launch this product in the US sometime in Q3 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, another pharmaceutical major from India. It will be exclusively manufactured and supplied for Wockhardt by Cipla from its FDA-approved facility in Goa.
January 09, 2009