Dr. Reddy's Laboratories announces the launch of Fluphenazine Hydrochloride Tablets, USP in the U.S. Market
February 18 2021 - 12:50AM
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 Fluphenazine
Hydrochloride Tablets, USP, a therapeutic equivalent generic
version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg,
approved by the U.S. Food and Drug Administration (USFDA).
The Prolixin brand and generic had U.S. sales of approximately
$134 million MAT for the most recent twelve months ending in
December 2020 according to IQVIA Health*.
Dr. Reddy’s Fluphenazine Hydrochloride Tablets, USP are
available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle
count sizes.
Please see the full prescribing information including boxed
warning.
https://www.drreddys.com/pi/fluphenazine_hcl_tabs_pi.pdf
WARNING
Increased
Mortality in Elderly Patients with Dementia-Related
Psychosis:
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk
of death. Analyses of seventeen placebo-controlled trials (modal
duration of 10 weeks), largely in patients taking atypical
antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of death in
placebo-treated patients. Over the course of a typical 10-week
controlled trial, the rate of death in drug-treated patients was
about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths
appeared to be either cardiovascular (e.g., heart failure, sudden
death) or infectious (e.g., pneumonia) in nature. Observational
studies suggest that, similar to atypical antipsychotic drugs,
treatment with conventional antipsychotic drugs may increase
mortality. The extent to which the findings of increased mortality
in observational studies may be attributed to the antipsychotic
drug as opposed to some characteristic(s) of the patients is not
clear. Fluphenazine hydrochloride is not approved for the treatment
of patients with dementia-related psychosis (see WARNINGS).
*IQVIA National Sales Perspective: Retail and Non-Retail MAT
December 2020
RDY-0221-330
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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