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
Disclaimer
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
S.A. CORPORATION.
*IMS National Sales Perspectives: Retail and
Non-Retail MAT September 2014
Contacts:
Dr. Reddy’s Laboratories
Media:
Shilpi
Lathia, +91-40- 49002448
shilpil@drreddys.com
or
Investors
and Financial Analysts:
Kedar Upadhye, +91-40-66834297
kedaru@drreddys.com
or
Saunak
Savla, +91-40-49002135
saunaks@drreddys.com
or
Ashish
Girotra (USA), +1 609-375-9805
ashishg@drreddys.com
Source: Dr. Reddy’s Laboratories
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