HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY)
announced today that it has received final approval from the U.S. Food
and Drug Administration (USFDA) and is launching Buprenorphine and
Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3
mg, a therapeutic equivalent generic version of Suboxone®
(buprenorphine and naloxone) sublingual film, in the United States
market. The product is being launched with an approved Risk Evaluation
and Mitigation Strategy (REMS) Program.**
Buprenorphine and naloxone are used to treat adults with opioid
dependence/addiction. Buprenorphine helps suppress withdrawal symptoms
caused by discontinuation of opioid drugs, and naloxone reverses and
blocks the effect of opioids. This combination of medications is used as
part of a complete treatment program including prescription monitoring,
counseling, and psychosocial support.
In a statement released earlier today by the USFDA, Commissioner Scott
Gottlieb, M.D., explained, “The FDA is taking new steps to advance the
development of improved treatments for opioid use disorder, and to make
sure these medicines are accessible to the patients who need them. That
includes promoting the development of better drugs, and also
facilitating market entry of generic versions of approved drugs to help
ensure broader access.”
“With opioid addiction becoming increasingly prevalent in America, the
full approval and launch of our generic equivalent of Suboxone®
could not have come at a more critical time to help patients,” explains
Alok Sonig, Chief Executive Officer, Developed Markets. “We are excited
to be launching this important product that will help enable patients to
prevail over this insidious disease.”
Sonig adds. “This approval is an important milestone for our company and
a testament to our commitment to bring affordable generic medicines to
market for patients. Our company will continue to look for opportunities
to acquire and manufacture assets that accelerate access to innovative
and affordable medicines for patients.”
The Suboxone® brand had U.S. sales of approximately $1.86
billion MAT for the most recent twelve months ending in April 2018
according to IMS Health*.
Important Safety Information
What important information should I know about Buprenorphine and
Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3
Buprenorphine and Naloxone Sublingual Film can cause serious and
life-threatening breathing problems. Call your doctor right away or get
emergency help as these can be signs of an overdose or other serious
- You feel faint, dizzy, or confused
- Your breathing gets much slower than is normal for you
Buprenorphine and Naloxone Sublingual Film contains an opioid that can
cause physical dependence.
Do not stop taking Buprenorphine and Naloxone Sublingual Film without
talking to your doctor. You could become sick with uncomfortable
withdrawal signs and symptoms because your body has become used to
An overdose and even death can happen if you take benzodiazepines,
sedatives, tranquilizers, antidepressants, or alcohol while using
Buprenorphine and Naloxone Sublingual Film. Ask your doctor what you
should do if you are taking one of these.
- Do not inject Buprenorphine and Naloxone Sublingual Film.
Injecting Buprenorphine and Naloxone Sublingual Film may cause
life-threatening infections and other serious health problems.
Injecting Buprenorphine and Naloxone Sublingual Film may cause serious
withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety,
sleep problems, and cravings.
In an emergency, have family members tell emergency department staff
that you are physically dependent on an opioid and are being treated
with Buprenorphine and Naloxone Sublingual Film.
Who should not use Buprenorphine and Naloxone Sublingual Film?
Do not take Buprenorphine and Naloxone Sublingual Film if you are
allergic to buprenorphine or naloxone.
What should I tell my healthcare provider before taking Buprenorphine
and Naloxone Sublingual Film? Before taking Buprenorphine and
Naloxone Sublingual Film, tell your doctor if you currently have or are:
- Liver or kidney problems
- Trouble breathing or lung problems
- An enlarged prostate gland (men)
- A head injury or brain problem
- Problems urinating
- A curve in your spine that affects your breathing
- Gallbladder problems
- Adrenal gland problems
- Addison’s disease
- Low thyroid (hypothyroidism)
- A history of alcoholism
Mental problems such as hallucinations (seeing or hearing things that
are not there)
- Any other medical condition
- Pregnant, plan to become pregnant, or are breastfeeding.
Tell your healthcare provider about all medications and herbal
products you take, including prescription and over-the-counter
medications, vitamins and herbal supplements.
Be especially careful about taking other medications that may make you
sleepy, such as pain medications, tranquilizers, antidepressant
medications, sleeping pills, anxiety medications or antihistamines.
What are possible side effects of Buprenorphine and Naloxone
Respiratory problems, sleepiness, dizziness, problems with coordination,
dependency or abuse, liver problems, allergic reactions, opioid
withdrawal, and decrease in blood pressure.
Call a doctor or get emergency help right away if you:
- Feel sleepy and uncoordinated
- Have blurred vision
- Have slurred speech
- Cannot think well or clearly
- Have slowed reflexes and breathing
The most common side effects of Buprenorphine and Naloxone Sublingual
- Drug withdrawal syndrome
- Numb mouth
- Swollen and/or painful tongue
- The inside of your mouth is more red than normal
- Intoxication (feeling lightheaded or drunk)
- Disturbance in attention
- Irregular heart beat (palpitations)
- Decrease in sleep (insomnia)
- Blurred vision
- Back pain
These are not all the possible side effects of Buprenorphine and
Naloxone Sublingual Film. Please refer to the Medication Guide for a
complete list of possible side effects associated with Buprenorphine and
Naloxone Sublingual Film.
KEEP BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 2 MG/0.5 MG, 4 MG/1 MG,
8 MG/2 MG, AND 12 MG/3 MG IN A SECURE PLACE AWAY FROM CHILDREN.
ACCIDENTAL USE BY A CHILD IS A MEDICAL EMERGENCY AND CAN RESULT IN
DEATH. IF A CHILD ACCIDENTALLY USES BUPRENORPHINE AND NALOXONE
SUBLINGUAL FILM, GET EMERGENCY HELP RIGHT AWAY.
What should I avoid while taking Buprenorphine and Naloxone
Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg?
Buprenorphine can cause drowsiness and slow reaction times. Do not
drive, operate heavy machinery, or perform any other physical
activities until you know how this medication affects you. This may
happen more often in the first few weeks of treatment when your dose
is being changed, but can also happen if you drink alcohol or take
other sedative drugs when you take Buprenorphine and Naloxone
You should not drink alcohol while using Buprenorphine and Naloxone
Sublingual Film as this can lead to loss of consciousness or even
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 Dr. Reddy’s Laboratories Medical
Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to firstname.lastname@example.org
or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/safety/medwatch.
Indication and Usage
Buprenorphine and Naloxone Sublingual Film is a prescription medication
used to treat adults who are addicted to (dependent on) opioid drugs
(either prescription or illegal) as part of a complete treatment program
that also includes counseling and behavioral therapy. Buprenorphine
helps suppress withdrawal symptoms caused by discontinuation of opioid
drugs, and naloxone reverses and blocks the effect of opioids.
Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8
mg/2 mg, and 12 mg/3 mg, is a controlled substance (CIII) because it
contains buprenorphine, which can be a target for people who abuse
prescription medications or street drugs. Keep your Buprenorphine and
Naloxone Sublingual Film in a safe place to protect it from theft. Never
give your Buprenorphine and Naloxone Sublingual Film to anyone else; it
can cause death or harm them. Selling or giving away this medication is
against the law.
Always take Buprenorphine and Naloxone Sublingual Film exactly as your
doctor tells you. Your doctor may change your dose after seeing how it
affects you. Do not change your dose unless your doctor tells you to
Do not take Buprenorphine and Naloxone Sublingual Film more often than
prescribed by your doctor.
Please click below for full Prescribing Information including
Suboxone® is a registered trademark of Indivior UK Ltd.
*IMS National Sales Perspective: Retail and Non-Retail MAT April 2018
information on REMS can be found at www.btodrems.com
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.
The company assumes no obligation to update any information contained