Lupin Ltd has received US FDA approval for its Abbreviated New Drug Application (ANDA) for Cephalexin for Oral Suspension USP, 125 mg/5 ml and 250 mg/5 ml.
This is Lupin’s sixth ANDA approved by the USFDA. Earlier, it had received approvals for Ceftriaxone for injection, Cefotaxime for injection, Cefuroxime Axetil tablets and Cefixime tablets and oral suspension.
A main stay cephalosporin antibiotic, Cephalexin is indicated for the treatment of Respiratory tract infections caused by S. pneumoniae and S. pyogenes, skin and skin structure infections caused by staphylococci and/or streptococci, bone infections caused by staphylococci and/or P. mirabilis and genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.
Lupin’s chairman Dr. Desh Bandhu Gupta said, “We have identified cephalosporins as one of our focus areas for the US market. The Approval for Cephalexin, will further boost our product basket. Given our leadership position in Cephalexin, we believe we will be able to drive value in the marketplace through forward-integration into the finished product.”