HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories (NYSE: RDY) announced today that is has launched Docetaxel Injection USP 20 mg/mL and 80 mg/4 mL a therapeutic equivalent generic version of TAXOTERE® (docetaxel Injection) in the US market on November 21, 2014. Dr. Reddy’s ANDA is approved by the United States Food & Drug Administration (USFDA).
The TAXOTERE® brand and generic has U.S. sales of approximately $218 Million MAT for the most recent twelve months ending in September 2014 according to IMS Health*.
Dr. Reddy’s Docetaxel Injection USP, 20 mg/mL and 80 mg/4 mL are available as a single dose, one vial formulation that does NOT require a prior dilution with a diluent and is ready to add to the Intravenous Infusion solution.
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
See full prescribing information for complete boxed warning
- Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel injection at 100 mg/m2
- Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle
- Should not be given if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia
- Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel injection and administration of appropriate therapy
- Contraindicated if history of severe hypersensitivity reactions to docetaxel injection or to drugs formulated with polysorbate 80
- Severe fluid retention may occur despite dexamethasone
This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com
TAXOTERE® is a registered trademark used by AVENTIS PHARMA
*IMS National Sales Perspectives: Retail and Non-Retail MAT September 2014