Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.
Levofloxacin in Dextrose Injection is an Anti-Infective used in the treatment of bacterial infection in adults. The approved product has an estimated market size of $46 million for the twelve months ending December 2015 according to IMS.
This is the 25th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. The company now has a total of 240 ANDA approvals (206 Final approvals including 10 from Aurolife Pharma LLC and 34 Tentative approvals) from USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1808.20 |
| Dr. Reddys Lab | 1322.95 |
| Cipla | 1309.90 |
| Zydus Lifesciences | 891.65 |
| Lupin | 2303.70 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: