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Please find enclosed a Press Release on
"Dr. Reddy's Laboratories received approval of XEGLYZE (abametapir) lotion, 0.74%, in the U.S. ."
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
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| Hyderabad - 500034. Telangana, India. | amita@drreddys.com | aparnatekuri@drreddys.com |
| (Ph: +91-40-49002135) | (Ph: +91-40- 49002446) |
Reddy's Laboratories received approval of XEGLYZE
lotion, 0.74%, in the U.S.
Hyderabad, India and Princeton, NJ, USA., July 27, 2020 - Dr.
Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr.
Reddy's") today announced approval of XEGLYZE (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug
Administration (USFDA). The approval triggers the contractual pre-commercialization milestone of $20 million payable to Hatchtech
Pty Ltd. XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. The company
is working to commercialize this product through partners.
INDICATION AND USAGE
XEGLYZE is indicated for the topical treatment of head lice
infestation in patients 6 months of age and older.
XEGLYZE should be used in the context of an overall lice management
Use a fine-tooth comb or special nit comb to remove dead lice
IMPORTANT SAFETY INFORMATION:
XEGLYZE contains benzyl alcohol. Systemic exposure to benzyl
alcohol has been associated with serious and fatal adverse reactions including "gasping syndrome" in neonates and low
birth weight infants. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis,
and gasping respirations. The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth
weight infants may be more likely to develop toxicity [see Use in Specific Populations (8.4)].
The safety and effectiveness of XEGLYZE have not been established
in pediatric patients below the age of 6 months. Use is not recommended in pediatric patients under 6 months of age because of
the potential for increased systemic absorption.
In order to prevent accidental ingestion in pediatric patients,
XEGLYZE should only be administered under direct supervision of an adult.
Ingestion of benzyl alcohol in large quantities may result in
gastrointestinal (nausea, vomiting, diarrhea) and central nervous system (headache, ataxia, convulsions, coma) adverse reactions.
Serious adverse reactions may include respiratory depression and death.
For 2 weeks after XEGLYZE application, avoid taking drugs that
are substrates of CYP3A4, CYP2B6 or CYP1A2. Otherwise, avoid use of XEGLYZE. (7)
Most common adverse reactions (incidence of 1%) were erythema,
rash, skin burning sensation, contact dermatitis, vomiting, eye irritation, pruritus, and hair color changes.(6.1)
These are not all the side effects associated with XEGLYZE.
Please see Patient Information, Instructions For Use, Medication
Guide and Full Prescribing Information for XEGLYZE.
You are encouraged to report negative side effects of prescription
drugs. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories. Inc., at 1-888-966-8766 or FDA at 1-800-FDA-1088
About Dr. Reddy's: Dr. Reddy's Laboratories
Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) 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, (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