Lupin Get USFDA approval for Ciprofloxacin and Doxyxycline
Mumbai Based Drug
Maker Lupin has received USFDA’S (US health regulator) approval to market a
generic version of Bayer’s Cipro in US Market.
Ciprofloxacin Oral Suspension will be available in following
versions:-
à 5 g/100 mL
(250 mg/5 mL)
à 10 g/100
mL (500 mg/5 mL)
This drug will be used for the treatment of
infections caused by susceptible isolates of the designated microorganisms in
various conditions and patient populations.
Lupin is the first applicant to file an abbreviated new drug application (ANDA) for Cipro oral suspension 250 mg/ml and 500 mg/ml and as such is entitled to 180-days of marketing exclusivity.
Lupin is the first applicant to file an abbreviated new drug application (ANDA) for Cipro oral suspension 250 mg/ml and 500 mg/ml and as such is entitled to 180-days of marketing exclusivity.
Lupin also get USFDA approvals for Doxycycline
Capsules a generic equivalent of Aqua
Pharmaceuticals Monodox®
àUSP 50 mg
à USP 75 mg
à100 mg
This will be used for the treatment of infections
caused by various microorganisms and as an adjunctive therapy in severe acne company said.
According to IMS(Integrated
Medical Systems International, Inc.) MAT Dec, 2013
Monodox® Capsules had
annual U.S sales of US$ 180.6 million
Cipro® Oral Suspension had annual U.S sales of
US$ 8.6 million
Lupin shares today closed at Rs 981.70 a piece on
the National Stock Exchange, down 0.72% from its previous close.