DUBLIN, July 2, 2018 /CNW/ -- Endo International plc
(NASDAQ: ENDP) announced today that one of its operating companies,
Par Pharmaceutical, Inc. (Par), has begun shipping an authorized
generic version of Takeda Pharmaceutical's Colcrys®
(colchicine, USP) 0.6 mg tablets. Endo's subsidiary, Endo
Ventures Limited, entered into an exclusive U.S. supply and
distribution agreement with Takeda Pharmaceuticals U.S.A., allowing Par to launch and distribute
an authorized generic of the product.
Colcrys® (colchicine, USP) 0.6 mg tablet is indicated
for prophylaxis and treatment of gout flares in adults and familial
Mediterranean fever (FMF) in adults and children 4 years or
older.i
Colcrys® is a trademark of Takeda Pharmaceuticals
U.S.A., Inc., registered with
the U.S. Patent and Trademark Office and used under license by
Takeda Pharmaceuticals America, Inc.
Important Safety Information
- COLCRYS can cause serious side effects or death if levels of
COLCRYS are too high in your body. Taking certain medicines with
COLCRYS can cause your level of COLCRYS to be too high, even at
recommended doses, especially if you have kidney or liver
problems.
- Tell your healthcare provider about all your medical conditions
and all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements, and
if you consume grapefruit juice.
- Fatal overdoses, both accidental and intentional, have been
reported in adults and children who have ingested colchicine. Keep
COLCRYS out of the reach of children.
- COLCRYS can also cause serious muscle problems and blood
disorders even when taken as directed. You have a higher chance for
muscle problems if you are elderly, are taking certain other
medicines with COLCRYS, or have kidney problems.
- Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
- The most common side effects in people who have gout flares are
diarrhea (23%) and throat pain (3%).
Use of COLCRYS
- COLCRYS (colchicine, USP) 0.6 mg tablet is a prescription
medicine used in adults to prevent and treat gout flares.
- COLCRYS is not a pain medicine and should not be taken to treat
pain related to other conditions.
Individual results may vary.
Please see the complete Prescribing Information
and Medication Guide and talk to your healthcare
professional.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
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.
References:
i COLCRYS (colchicine, USP)
Prescribing Information. Takeda Pharmaceuticals.
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SOURCE Endo International plc