NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug
Administration (FDA) has granted pediatric exclusivity for LYRICA®.
This grant extends the period of U.S. market exclusivity for LYRICA by
an additional six months, to June 30, 2019.
LYRICA is currently approved in the U.S. for fibromyalgia, diabetic
nerve pain, spinal cord injury nerve pain and pain after shingles in
adults. LYRICA is also approved as adjunctive therapy for the treatment
of partial onset seizures in patients four years of age and older.
The pediatric exclusivity determination is based on data from the LYRICA
Pediatric Epilepsy Program, which were submitted in response to the
FDA’s Written Request to Pfizer to evaluate the use of LYRICA as
adjunctive therapy for partial onset seizures in pediatric epilepsy
patients. These were also required post-marketing studies.
Important Safety Information
LYRICA is not for everyone. LYRICA may cause serious, even life
threatening, allergic reactions. Stop taking LYRICA and call your doctor
right away if you have any signs of a serious allergic reaction. Some
signs are swelling of your face, mouth, lips, gums, tongue, throat or
neck or if you have any trouble breathing, or have a rash, hives or
blisters.
Drugs used to treat seizures increase the risk of suicidal thoughts or
behavior. LYRICA may cause suicidal thoughts or actions in a very small
number of people, about 1 in 500. Patients, family members or caregivers
should call the doctor right away if they notice suicidal thoughts or
actions, thoughts of self harm, or any unusual changes in mood or
behavior. These changes may include new or worsening depression,
anxiety, restlessness, trouble sleeping, panic attacks, anger,
irritability, agitation, aggression, dangerous impulses or violence, or
extreme increases in activity or talking. If you have suicidal thoughts
or actions, do not stop LYRICA without first talking to your doctor.
LYRICA may cause swelling of your hands, legs and feet, which can be
serious for people with heart problems. LYRICA may cause dizziness and
sleepiness. You should not drive or work with machines until you know
how LYRICA affects you. Also, tell your doctor right away about muscle
pain or problems along with feeling sick and feverish, or any changes in
your eyesight including blurry vision or if you have any kidney problems
or get dialysis.
Some of the most common side effects of LYRICA are dizziness, blurry
vision, weight gain, sleepiness, trouble concentrating, swelling of your
hands and feet, dry mouth, and feeling “high.” If you have diabetes,
tell your doctor about any skin sores.
You may have a higher chance for swelling and hives if you are also
taking angiotensin-converting enzyme (ACE) inhibitors so tell your
doctor if you are taking these medications. You may have a higher chance
of swelling of your hands or feet or gaining weight if you are also
taking certain diabetes medicines. Do not drink alcohol while on LYRICA.
You may have a higher chance for dizziness and sleepiness if you take
LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.
Before you start LYRICA, tell your doctor if you are planning to father
a child, or if you are pregnant, or plan to become pregnant.
Breastfeeding is not recommended while taking LYRICA. If you have had a
drug or alcohol problem, you may be more likely to misuse LYRICA.
In studies, a specific type of blood vessel tumor was seen in mice, but
not in rats. The meaning of these findings in humans is not known.
Do not stop taking LYRICA without talking to your doctor. If you stop
suddenly you may have headaches, nausea, diarrhea, trouble sleeping,
increased sweating, or you may feel anxious. If you have epilepsy, you
may have seizures more often.
Please click here
for the full prescribing information and Medication Guide for LYRICA or
visit http://www.lyrica.com/.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com and
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DISCLOSURE NOTICE: The information contained in this release is as of
November 27, 2018. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about LYRICA
(pregabalin), including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the uncertainties
inherent in research and development; uncertainties regarding the
ability to protect and enforce intellectual property and other
proprietary rights; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of LYRICA; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2017 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at
www.sec.gov
and
www.pfizer.com
.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181127005811/en/
Media:
Neha Wadhwa
(212) 733-2835
Neha.Wadhwa@pfizer.com
Investor:
Ryan
Crowe
(212) 733-8160
Ryan.Crowe@Pfizer.com
Source: Pfizer Inc.