BRIDGEWATER, N.J., Feb. 5, 2018 /PRNewswire/ -- Amneal
Pharmaceuticals has launched methylphenidate hydrochloride
extended-release tablets, USP (CII) in 18, 27, 36, and 54 mg
strengths.
Amneal's methylphenidate is an AB-rated equivalent to the brand
Concerta®. The Amneal ANDA included all
bioequivalence metrics recommended by FDA.
"We are extremely pleased to add our methylphenidate to the list
of therapeutically equivalent generics for Concerta," commented
Amneal EVP - Sales & Marketing Jim
Luce. "The entrance of another AB-rated option adds to the
choices provided to patients, prescribers and payers beyond
non-substitutable BX-rated products and the brand."
Methylphenidate hydrochloride ER tablets are now shipping to
wholesalers, distributors and direct to the trade. All strengths
are available in 90-ct bottles with a 30-ct size available upon
request. The product is manufactured in the U.S.A. at the Amneal plant in Brookhaven, New York.
Annual U.S. sales of methylphenidate ER were $1.5 billion, according to December 2017 IQVIA®
market data.
Click here for full prescribing information, including boxed
warning and important safety considerations.
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:
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Sales
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Business
Development
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Jim
Luce
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Apurva
Saraf
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Executive Vice
President, Sales & Marketing
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Vice President,
Global Strategy & Corporate
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949.432.1389
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Development
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jim.luce@amneal.com
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631.742.7674
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apurvas@amneal.com
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Media
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Cheryl
Lechok
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Media
Relations
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203.613.1506
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mediarelations@amneal.com
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SOURCE Amneal Pharmaceuticals