Wockhardt gets US FDA approval for paediatrics drug
04 Dec 2008
The US Food and Drugs Administration (FDA) has approved Wockhardt's oral Augmentin suspension for marketing in the US. The oral suspension, a combination of amoxycillin and clavulanate potassium is sold in the US by Glaxo SmithKline under the brand name Augmentin 250.
Workhardt chairman Habil Khorakiwala said that Wockhardt has become the first company to receive an ANDA approval for the strength of Augmentin.
Wockhardt's Chicago-based subsidiary Morton Grove Pharmaceuticals has also received approval from the US FDA 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 children, he said
The product was developed in collaboration with Cipla Limited, another Indian pharmaceutical major. It will be exclusively manufactured for Wockhardt at Cipla's FDA approved facility in Goa, India.
Augmentin is slated for launch in the US sometime in Q3 2009. According to analysts the market for the product in the US is about $32 million.
Workhardt has been consistently growing market shares for all its products in the prescription generic pharmaceutical market in US. It markets over sixty products through Morton Grove which is a leader in generic liquid products in the US, manufacturing over 30 products at its facility near Chicago.
Wockhardt Limited, the Indian pharmaceutical and biotechnology major operates 15 manufacturing plants that are US FDA, MHRA or approved by other bodies, in several countries across the globe.