US FDA approves Lupin's cefprozil suspension, Orchid's tablets
By Our Corporate Bureau | 20 Dec 2005
Lupin Ltd has announced having received the US FDA approval for its abbreviated new drug application (ANDA) for cefprozil oral suspension in dosages of 125mg per 5ml and 250mg per 5ml. Cefprozil is the generic equivalent of Bristol Myers Squibb''s Cefzil. The suspension market in the US is valued at $119 million. Earlier this month, the company had received approval from the US FDA for cefprozil tablets.
This is Lupin''s 10th ANDA approval by the US FDA till date and the fifth in this financial year.
In another development, the US FDA has granted approval for Orchid Chemicals & Pharmaceuticals Ltd ANDA for Cefprozil Tablets USP, 250mg and 500mg. The current US market size for Cefprozil tablets is valued at $117 million.
Orchid will launch the product exclusively through Par Pharmaceuticals immediately upon the expiry of the patent on December 23.
This is the eighth cephalosporin ANDA approval Orchid has received covering four cephalosporin products in various dosage forms. The company expects more ANDA approvals to follow in the months to come. As of date, it has filed 21 ANDAs with the US FDA.