Dr. Reddy's Laboratories Announces its Launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S.
10 Agosto 2023 - 6:00AM
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 its launch of
Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in
the U.S. market, a therapeutic equivalent generic version of
KOMBIGLYZE® XR (saxagliptin and metformin hydrochloride extended
release) tablets, approved by U. S. Food and Drug Administration
(USFDA).
Dr. Reddy’s Saxagliptin and Metformin Hydrochloride
Extended-Release Tablets are supplied in a strength of 2.5 mg/1000
mg in bottle count of 60 and strengths of 5 mg/500 mg and 5 mg/1000
mg each in bottle counts of 30.
Please click here to see the full prescribing information,
including boxed warning:
https://drreddys.com/pil/150092247-PIL-Saxagl-Met-HCL-ER-Tab-US_V3_fn.pdf.
WARNING: LACTIC
ACIDOSIS
See full prescribing
information for complete boxed warning.
- Post-marketing cases of metformin-associated lactic acidosis
have resulted in death, hypothermia, hypotension, and resistant
bradyarrhythmias. Symptoms included malaise, myalgias, respiratory
distress, somnolence, and abdominal pain. Laboratory abnormalities
included elevated blood lactate levels, anion gap acidosis,
increased lactate/pyruvate ratio; and metformin plasma levels
generally >5 mcg/mL. (5.1)
- Risk factors include renal impairment, concomitant use of
certain drugs, age >65 years old, radiological studies with
contrast, surgery and other procedures, hypoxic states, excessive
alcohol intake, and hepatic impairment. Steps to reduce the risk of
and manage metformin-associated lactic acidosis in these high-risk
groups are provided in the Full Prescribing Information. (5.1)
- If lactic acidosis is suspected, discontinue saxagliptin and
metformin hydrochloride extended-release tablets and institute
general supportive measures in a hospital setting. Prompt
hemodialysis is recommended. (5.1)
KOMBIGLYZE® is a registered trademark of the AstraZeneca group
of companies.
RDY-0723-570
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global
pharmaceutical company headquartered in Hyderabad, India.
Established in 1984, we are committed to providing access to
affordable and innovative medicines. Driven by our purpose of ‘Good
Health Can’t Wait’, we offer a portfolio of products and services
including APIs, generics, branded generics, biosimilars and OTC.
Our major therapeutic areas of focus are gastrointestinal,
cardiovascular, diabetology, oncology, pain management and
dermatology. Our major markets include – USA, India, Russia &
CIS countries, China, Brazil and Europe. As a company with a
history of deep science that has led to several industry firsts, we
continue to plan ahead and invest in businesses of the future. As
an early adopter of sustainability and ESG actions, we released our
first Sustainability Report in 2004. Our current ESG goals aim to
set the bar high in environmental stewardship; access and
affordability for patients; diversity; and governance. 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, 2023. The
company assumes no obligation to update any information contained
herein.
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INVESTOR RELATIONS RICHA PERIWAL richaperiwal@drreddys.com
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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