Dr. Reddy's Laboratories Announces the Launch of Capecitabine Tablets, USP in the U.S. Market
February 17 2021 - 5:11AM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred
to as “Dr. Reddy’s”) today announced the launch of Capecitabine
Tablets, USP a therapeutic equivalent generic version of Xeloda
(capecitabine) Tablets approved by the U.S. Food and Drug
Administration (USFDA).
The Xeloda brand and generic had U.S. sales of approximately $90
million MAT for the most recent twelve months ending in October
2020 according to IQVIA Health*.
Dr. Reddy’s Capecitabine Tablets, USP are available in 150 mg
and 500 mg strengths in bottle count sizes of 60 and 120,
respectively.
Please see the full prescribing information including boxed
warning. https://www.drreddys.com/pi/capecitabine_usp_tabs.pdf
WARNING: CAPECITABINE-WARFARIN
INTERACTION
Capecitabine Warfarin Interaction:
Patients receiving concomitant capecitabine and oral
coumarin-derivative anticoagulant therapy should have their
anticoagulant response (INR or prothrombin time) monitored
frequently in order to adjust the anticoagulant dose accordingly. A
clinically important Capecitabine-Warfarin drug interaction was
demonstrated in a clinical pharmacology trial [see Warnings and
Precautions (5.2) and Drug Interactions (7.1)]. Altered coagulation
parameters and/or bleeding, including death, have been reported in
patients taking capecitabine concomitantly with coumarin-derivative
anticoagulants such as warfarin and phenprocoumon. Postmarketing
reports have shown clinically significant increases in prothrombin
time (PT) and INR in patients who were stabilized on anticoagulants
at the time capecitabine was introduced. These events occurred
within several days and up to several months after initiating
capecitabine therapy and, in a few cases, within 1 month after
stopping capecitabine. These events occurred in patients with and
without liver metastases. Age greater than 60 and a diagnosis of
cancer independently predispose patients to an increased risk of
coagulopathy.
Xeloda is a trademark of Hoffmann-La Roche Inc.
*IQVIA Retail and Non-Retail MAT October 2020.
RDY-1220-322
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Through its three
businesses - Pharmaceutical Services & 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. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates, interest rates, persistency
levels and frequency / severity of insured loss events, (ii)
mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no
obligation to update any information contained herein.”
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135) MEDIA RELATIONS APARNA TEKURI
aparnatekuri@drreddys.com (PH: +91-40- 49002446)
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