Dr. Reddy's Laboratories announces the launch of Febuxostat Tablets in the U.S. Market
January 11 2021 - 4:59AM
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
Febuxostat Tablets, a therapeutic equivalent generic version of
Uloric (Febuxostat) Tablets approved by the U.S. Food and Drug
Administration (USFDA).
The Uloric brand and generic had U.S. sales of approximately
$108 million MAT for the most recent twelve months ending in
October 2020 according to IQVIA Health*.
Dr. Reddy’s Febuxostat Tablets are available in 40 mg and 80 mg
strengths in bottle count sizes of 30 tablets.
Please see the full prescribing information including boxed
warning. https://www.drreddys.com/pi/febuxostat_tablets.pdf
WARNING: CARDIOVASCULAR
DEATH
Gout patients with established
cardiovascular (CV) disease treated with Febuxostat had a higher
rate of CV death compared to those treated with allopurinol in a CV
outcomes study [see Warnings and Precautions (5.1)].
Consider the risks and benefits of
Febuxostat when deciding to prescribe or continue patients on
Febuxostat. Febuxostat should only be used in patients who have an
inadequate response to a maximally titrated dose of allopurinol,
who are intolerant to allopurinol, or for whom treatment with
allopurinol is not advisable [see Indications and Usage (1)].
Uloric is a trademark of TEIJIN KABUSHIKI KAISHA (TEIJIN
LIMITED) *IQVIA Retail and Non-Retail MAT October 2020.
RDY-0121-323
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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version on businesswire.com: https://www.businesswire.com/news/home/20210111005471/en/
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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