BRIDGEWATER, N.J., Feb. 1, 2018 /PRNewswire/ -- Amneal
Pharmaceuticals has launched isotretinoin capsules, USP, an
AB-rated generic for Accutane® in 10 mg, 20 mg, 30 mg and 40 mg
strengths. The product is available in cartons containing 3 blister
packs of 10 capsules each.
Amneal's generic received FDA approval under a Risk Evaluation
and Mitigation Strategy (REMS) known as the iPledge program.
Information on this REMS program is available at
https://ipledgeprogram.com or 866-495-0654.
Visit
http://www.amneal.com/wp-content/uploads/2018/01/Isotretinoin-PI.pdf
to view full prescribing information for isotretinoin capsules.
Annual U.S. sales of isotretinoin capsules were $250 million, according to December 2017 IQVIA™ market data. Isotretinoin
capsules began shipping today.
About Amneal
Amneal Pharmaceuticals LLC, a privately-held company
headquartered in Bridgewater, New
Jersey, is one of the largest and the fastest growing
generics pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now
has more than 5,000 employees in North
America, Asia and
Europe, working together to bring
high quality affordable medicines to patients worldwide. Amneal has
significantly expanded its portfolio of generic products to include
complex dosage forms in a broad range of therapeutic areas.
Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. (NASDAQ:
IPXL) announced on October 17, 2017
that they have entered into a definitive business combination
agreement with the resulting combined company expected to create
the 5th largest generics business (by gross revenue) in
the United States. The transaction
is expected to close in the first half of 2018.
For more information, visit amneal.com.
All trademarks listed in this release are property of their
respective owners.
Product photo is available upon request.
CONTACTS:
Sales
Jim Luce
EVP-Sales & Marketing
949.432.1389
jim.luce@amneal.com
Media
Cheryl Lechok
Media Relations
203.613.1506
mediarelations@amneal.com
Business Development
Apurva
Saraf
VP, Global Strategy & Corporate Development
631.742.7674
apurvas@amneal.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/amneal-introduces-isotretinoin-capsules-usp-300591912.html
SOURCE Amneal Pharmaceuticals