DUBLIN, Aug. 28, 2017 /CNW/ -- Endo
International plc (NASDAQ: ENDP) announced today that one of its
operating companies, Par Pharmaceutical, has begun shipping
vigabatrin for oral solution USP, 500 mg per packet following final
approval from the U.S. Food and Drug Administration for its
Abbreviated New Drug Application. Par's vigabatrin for oral
solution is the generic version of Lundbeck LLC's Sabril® and is
the first and currently the only generic version available.
Vigabatrin is available only through certified healthcare
providers and specialty pharmacies.
"We are pleased to be able to offer patients a cost-effective
option to Sabril®," said Tony Pera,
President of Par Pharmaceutical. "Par's vigabatrin for oral
solution is therapeutically equivalent to the brand and is
therefore substitutable. We are proud to continue our tradition at
Par of providing high quality, affordable medicines."
According to IMS Health data, U.S. sales of Sabril® for oral
solution were approximately $329M for
the 12 months ended June 2017.
Sabril® is a registered trademark of Lundbeck.
About Endo International plc
Endo International plc
(NASDAQ: ENDP) is a highly focused generics and specialty branded
pharmaceutical company delivering quality medicines to patients in
need through excellence in development, manufacturing and
commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
About Par Pharmaceutical
Par Pharmaceutical,
headquartered in Chestnut Ridge,
NY, develops, manufactures and markets safe, innovative and
cost-effective generic pharmaceutical products that help improve
patient quality of life. Par, among the top four leaders in the
U.S. generics industry, possesses a portfolio that includes sterile
injectables, alternative dosage forms and many other differentiated
products. Par is advancing a research and development
(R&D) pipeline of more than 200 potential new products.
Par is an operating company of Endo International plc. Learn more
at www.endo.com or www.parpharm.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements, including the statements by Mr. Pera, within the
meaning of the Private Securities Litigation Reform Act of 1995 and
Canadian securities legislation. Because these statements reflect
Endo's current views, expectations and beliefs concerning future
events, these forward-looking statements involve risks and
uncertainties. Although Endo believes that these forward-looking
statements and information are based upon reasonable assumptions
and expectations, readers should not place undue reliance on them,
or any other forward-looking statements or information in this news
release. Investors should note that many factors, as more fully
described in the documents filed by Endo with the Securities and
Exchange Commission ("SEC") and with securities regulators in
Canada on the System for
Electronic Document Analysis and Retrieval ("SEDAR), and as
otherwise enumerated herein or therein, could affect Endo's future
financial results and could cause Endo's actual results to differ
materially from those expressed in this communication. The
forward-looking statements in this press release are qualified by
these risk factors. Endo does not assume any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise, except as may be
required under applicable securities laws.
Important Safety Information
Vigabatrin for oral solution – Consumer Indication and
Important Safety Information
What is vigabatrin for oral solution?
Vigabatrin for oral solution is a prescription medicine used
with other treatments in adults and children 10 years of age and
older with refractory complex partial seizures (CPS) who have not
responded well enough to several other treatments and if the
possible benefits outweigh the risk of vision loss. Vigabatrin
should not be the first medicine used to treat CPS.
Vigabatrin is a prescription medicine used in babies, 1 month to
2 years old, with infantile spasms, if the possible benefits
outweigh the possible risk of vision loss.
WARNING: PERMANENT VISION LOSS
See Medication Guide and full Prescribing
Information for complete information.
All people who take vigabatrin for oral solution:
- You are at risk for permanent vision loss with any
amount of vigabatrin for oral solution.
- Your risk of vision loss may be higher the more
vigabatrin for oral solution you take daily and the longer you take
it.
- It is not possible for your healthcare provider to know when
vision loss will happen. It could happen soon after starting
vigabatrin for oral solution or any time during treatment. It may
even happen after treatment has stopped.
IMPORTANT SAFETY INFORMATION about vigabatrin for oral
solution
- Because vigabatrin for oral solution might cause permanent
vision loss, it is available to healthcare providers and patients
only under a special program called the vigabatrin Risk Evaluation
and Mitigation Strategy (REMS) Program. Vigabatrin for oral
solution can only be prescribed to people who are enrolled in this
program. Your healthcare provider will explain the details of this
program to you.
- Vigabatrin for oral solution can damage the vision of anyone
who takes it. People who take vigabatrin for oral solution do not
lose all of their vision, but some people can have severe loss
particularly to their ability to see to the side when looking
straight ahead (peripheral vision). With severe vision loss, you
may only be able to see things straight in front of you (sometimes
called "tunnel vision"). You may also have blurry vision. If this
happens, it will not get better.
- Tell your healthcare provider right away if you (or
your child): might not be seeing as well as before starting
vigabatrin for oral solution; start to trip, bump into things, or
are more clumsy than usual; are surprised by people or things
coming in front of you that seem to come out of nowhere; or if your
baby is acting differently than normal. These changes can mean that
vision damage has occurred.
- It is recommended that your healthcare provider test your
(or your child's) vision before or within 4 weeks after starting
vigabatrin for oral solution, and at least every 3 months during
treatment until vigabatrin for oral solution is stopped. It is also
recommended that vision be tested about 3 to 6 months after
vigabatrin for oral solution is stopped. It is difficult to test
vision in babies, but to the extent possible, all babies should
have their vision tested. Your healthcare provider will determine
if testing can be done. Regular vision testing is important because
damage can happen before any changes are noticed.
- Vision tests cannot prevent the vision damage that can
happen with vigabatrin for oral solution, but they do allow
vigabatrin for oral solution to be stopped if vision has gotten
worse, which usually will lessen further damage. Even these regular
vision tests may not show vision damage before it is serious and
permanent. Once detected, vision loss is not reversible. Parents,
caregivers, and healthcare providers may not recognize the
symptoms, or find vision loss in babies, until it is severe. Less
severe vision loss can still negatively affect function.
- If vision tests are not done regularly, your healthcare
provider may stop prescribing vigabatrin for oral solution for you
(or your child). Some people are not able to complete vision
testing. If vision testing cannot be done, your healthcare provider
may continue prescribing vigabatrin for oral solution, but will not
be able to watch for any vision loss.
- Brain pictures taken by magnetic resonance imaging (MRI) show
changes in some babies after they are given vigabatrin for oral
solution. It is not known if these changes are harmful.
- Like other antiepileptic drugs, vigabatrin for oral solution
may cause suicidal thoughts and actions in some people. Call a
healthcare provider right away if you (or your child) have any of
these symptoms: thoughts about suicide or dying, new or worse
depression, feeling agitated or restless, trouble sleeping
(insomnia), acting aggressive, being angry, or violent, an extreme
increase in activity and talking (mania), attempts to commit
suicide, new or worse anxiety, panic attacks, new or worse
irritability, acting on dangerous impulses, other unusual changes
in behavior or mood; and especially if they are new, worse, or
worry you.
- Do not stop vigabatrin without first talking to a healthcare
provider. Stopping vigabatrin for oral solution suddenly can cause
seizures that will not stop in people who are being treated for
seizures.
- Vigabatrin for oral solution can cause serious side effects
such as low red blood cell counts (anemia), sleepiness and
tiredness, nerve problems, weight gain, and swelling. Because
vigabatrin for oral solution causes sleepiness and tiredness, do
not drive, operate machinery, or perform any hazardous task, unless
it is decided that these things can be done safely. Vigabatrin for
oral solution may make certain types of seizures worse. Tell your
healthcare provider right away if seizures get worse.
- Before starting vigabatrin for oral solution, tell your doctor
about all of your (or your child's) medical conditions, including
depression, mood problems, suicidal thoughts or behavior, any
allergic reaction to vigabatrin for oral solution, vision problems,
kidney problems, low red blood cell counts (anemia), and any
nervous or mental illness. Tell your doctor about all the medicines
you (or your child) take.
- If you are breastfeeding or plan to breastfeed, vigabatrin for
oral solution can pass into breast milk and may harm your baby. If
you are pregnant or plan to become pregnant, it is not known if
vigabatrin for oral solution will harm your unborn baby. You and
your healthcare provider will have to decide if you should take
vigabatrin for oral solution while you are pregnant.
- The most common side effects of vigabatrin for oral solution in
adults include: problems walking or feeling uncoordinated, feeling
dizzy, shaking (tremor), joint pain, memory problems and not
thinking clearly, and eye problems like blurry vision, double
vision, and eye movements that cannot be controlled. The most
common side effects of vigabatrin for oral solution in children 10
to 16 years of age include weight gain, upper respiratory tract
infection, tiredness, and aggression. Also expect side effects like
those seen in adults.
- The most common side effects of vigabatrin for oral solution in
babies include: sleepiness—some babies may have a harder time
suckling and feeding or may be irritable, swelling in the bronchial
tubes (bronchitis), ear infection, and irritability.
- Tell your healthcare provider if you or your child have any
side effect that bothers you or that does not go away. These are
not all of the possible side effects of vigabatrin for oral
solution. For more information, ask your healthcare provider or
pharmacist.
Please see the full Prescribing Information, including Boxed
Warning and Medication Guide at
vigabatrin.com/assets/pdfs/VIGABATRIN_PI.pdf.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-332-1088.
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SOURCE Endo International plc