Full Press Release Details
ZEMBRACETM SymTouchTM (sumatriptan
injection) 3 mg, approved by the FDA in
January 2016 for the acute treatment of migraine with or without aura in adults, is
now commercially available in the U.S.
Hyderabad, India and Princeton, NJ, USA. April 19, 2016 Promius Pharma LLC, a subsidiary of Dr. Reddy s Laboratories (BSE: 500124, NSE:
DRREDDY, NYSE: RDY), announced today that ZEMBRACE SymTouch is now commercially available in the U.S.
ZEMBRACE SymTouch is a prefilled,
low-dose, ready-to-use, 2-step autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. Because ZEMBRACE SymTouch is a subcutaneous injection, it may lead to
rapid relief of migraine.
Migraineurs often have more than one kind of attack. Different types of medications can be used to treat different types of
attacks. ZEMBRACE SymTouch is a welcome addition to the toolkit for acute treatment of migraine said Roger Cady, MD, Associate Executive Chairman of the National Headache Foundation. This 3-mg, easy to-use subcutaneous
injection of sumatriptan may be desired by many migraine patients who need a medication that can rapidly treat migraine attacks. Also, the 3-mg dose allows for up to 4 doses of ZEMBRACE SymTouch in a 24-hour period, thus allowing dosing
flexibility for patients. ZEMBRACE SymTouch is available as a box of 4 autoinjectors.
Dr. Reddy s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to accelerating access to affordable and innovative medicines, because it believes Good Health Can t Wait. Through
its three businesses Pharmaceutical Services & Active Ingredients , Global Generics and Proprietary Products the company offers a portfolio of products and services that include active pharmaceutical ingredients, (APIs), custom
pharmaceutical services, generics, biosimilars and differentiated formulations. With operations in 26 countries across the globe, the major therapeutic areas of Dr. Reddy s are gastro-intestinal, cardiovascular, diabetology, oncology, pain
management and anti-infectives. 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 reorganisation , including related integration issues.
assumes no obligation to update any information contained herein.
Co-pay assistance for ZEMBRACE SymTouch may be available for eligible patients. For more information about
eligibility, visit www.zembrace.com.
ZEMBRACETM SymTouchTM (sumatriptan injection) 3 mg Use and Important Safety Information
ZEMBRACE SymTouch is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been
diagnosed with migraine. ZEMBRACE SymTouch is not used to prevent or decrease the number of migraines you have. It is not known if ZEMBRACE SymTouch is safe and effective in children under 18 years of age.
What important information should I know about ZEMBRACE SymTouch?
ZEMBRACE SymTouch can cause serious side effects, including: heart attack and other heart problems, which may lead to death. Stop using ZEMBRACE SymTouch
and get emergency medical help right away if you have any of the following symptoms of a heart attack:
chest pain or chest discomfort that feels like
an uncomfortable heavy pressure, tightness or heaviness, or pain that lasts for more than a few minutes, or that goes away and comes back
ZEMBRACE SymTouch is not for people with risk factors for heart disease (high blood
pressure, high cholesterol levels, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.
Who should not use ZEMBRACE SymTouch?
ZEMBRACE SymTouch if you have:
What should I tell my healthcare
provider before taking ZEMBRACE SymTouch?
Tell your healthcare provider about all of your medical conditions, and about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while using ZEMBRACE SymTouch?
ZEMBRACE SymTouch can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to
What are possible side effects of ZEMBRACE SymTouch?
ZEMBRACE SymTouch may cause serious side effects including:
The most common side effects of ZEMBRACE SymTouch include pain and redness at your injection site;
tingling or numbness in your fingers or toes; dizziness; warm hot burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.
These are not all the possible side effects of ZEMBRACE SymTouch. For more information, ask your healthcare provider or pharmacist. You are
encouraged to report negative side effects of prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/Safety/MedWatch
Please see Patient Information, Instructions For Use and Full Prescribing Information for ZEMBRACE SymTouch or visit
Migraine affects millions of patients. Rapid pain relief is important to help them manage through their daily routines. Multiple factors such as nausea,
vomiting, and/or other gastric disturbances may impact the response to oral medications and make these patients potential candidates for other modes of medication delivery including injectables.
About Promius Pharma LLC
Promius Pharma is a wholly
owned subsidiary of Dr. Reddy s Laboratories, one of largest and most respected pharmaceutical companies in the world. With a robust commercial infrastructure and extensive research and development capabilities through its parent
company, Promius Pharma is committed to bringing new products to market that meet patients needs in dermatology and neurology. For more information, visit www.promiuspharma.com.
Contact information (USA):
Ashish Girotra (USA)
ashishg@drreddys.com Phone: +1
lmccreary@drreddys.com Phone +1 (609) 375-2955
ZEMBRACE and SymTouch are registered trademarks of Dr. Reddy s Laboratories Limited