|
|
BY OUR PHARMA CORRESPONDENT
13 September,2005: Indian pharmaceutical firm Lupin's cephalexin oral suspension has been received marketing approval from US Food and Drug Administration.
The approval has been granted for two strengths of the antibiotic: 125 mg/5 ml and 250 mg/5 ml, the company announced in a press release.
This is Lupin’s sixth generic drug 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.
Headquartered in Mumbai, Lupin develops, manufactures and markets generic intermediates, active pharmaceutical ingredients and finished dosages. Its FY 2004-05 revenues were Rs.12 billion. 11 of Lupin’s plant have been approved by the USFDA and two facilities have been approved by the UKMHRA.
BY OUR PHARMA CORRESPONDENT |
