HAYWARD, Calif., Sept. 22, 2016 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL) today announced the
launch of a generic version of Metadate CD®
(methylphenidate hydrochloride extended-release capsules), 10 mg,
20 mg, 30 mg, 40 mg, 50 mg, and 60 mg.
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Impax is focused on further enhancing its portfolio of 73 solid
oral dose and alternative dosage form generic products available.
The launch of methylphenidate hydrochloride is Impax's sixth new
product launch since the beginning of 2016.
Methylphenidate hydrochloride extended-release capsules had
annual combined brand and generic sales of approximately
$151 million in the United States, according to IMS Health
(NSP) for the 12 months ending in July
2016.
For full Prescribing Information see
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bce4cf37-d6a3-4203-b45d-6d1c35510eec
About Impax Laboratories, Inc.
Impax Laboratories,
Inc. (Impax) is a specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the
development of controlled-release and specialty generics in
addition to the development of central nervous system disorder
branded products. Impax markets its generic products through its
Impax Generics division and markets its branded products through
its Impax Specialty Pharma division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platforms and pursues partnership
opportunities that offer alternative dosage form technologies, such
as injectables, nasal sprays, inhalers, patches, creams and
ointments. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical; these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company's future results, performance, or
achievements to differ significantly from the results, performance,
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to: fluctuations in revenues and operating income; the
Company's ability to successfully develop and commercialize
pharmaceutical products in a timely manner; reductions or loss of
business with any significant customer; the substantial portion of
the Company's total revenues derived from sales of a limited number
of products; the impact of consolidation of the Company's customer
base; the impact of competition; the Company's ability to sustain
profitability and positive cash flows; any delays or unanticipated
expenses in connection with the operation of the Company's
manufacturing facilities; the effect of foreign economic,
political, legal, and other risks on the Company's operations
abroad; the uncertainty of patent litigation and other legal
proceedings; the increased government scrutiny on the Company's
agreements with brand pharmaceutical companies; product development
risks and the difficulty of predicting FDA filings and approvals;
consumer acceptance and demand for new pharmaceutical products; the
impact of market perceptions of the Company and the safety and
quality of the Company's products; the Company's determinations to
discontinue the manufacture and distribution of certain products;
the Company's ability to achieve returns on its investments in
research and development activities; changes to FDA approval
requirements; the Company's ability to successfully conduct
clinical trials; the Company's reliance on third parties to conduct
clinical trials and testing; the Company's lack of a license
partner for commercialization of NUMIENTTM (IPX066) outside of
the United States; impact of
illegal distribution and sale by third parties of counterfeits or
stolen products; the availability of raw materials and impact of
interruptions in the Company's supply chain; the Company's policies
regarding returns, allowances and chargebacks; the use of
controlled substances in the Company's products; the effect of
current economic conditions on the Company's industry,
business, results of operations and financial condition;
disruptions or failures in the Company's information technology
systems and network infrastructure caused by third party breaches
or other events; the Company's reliance on alliance and
collaboration agreements; the Company's reliance on licenses to
proprietary technologies; the Company's dependence on certain
employees; the Company's ability to comply with legal and
regulatory requirements governing the healthcare industry; the
regulatory environment; the effect of certain provisions in the
Company's government contracts; the Company's ability to protect
its intellectual property; exposure to product liability claims;
risks relating to goodwill and intangibles; changes in tax
regulations; the Company's ability to manage growth, including
through potential acquisitions and investments; the risks
related to the Company's acquisitions of or investments in
technologies, products or businesses; the restrictions imposed by
the Company's credit facility and indenture; the Company's level of
indebtedness and liabilities and the potential impact on cash
flow available for operations; uncertainties involved in the
preparation of the Company's financial statements; the Company's
ability to maintain an effective system of internal control over
financial reporting; the effect of terrorist attacks on the
Company's business; the location of the Company's manufacturing and
research and development facilities near earthquake fault lines;
expansion of social media platforms and other risks described in
the Company's periodic reports filed with the Securities and
Exchange Commission. Forward-looking statements speak only as to
the date on which they are made, and the Company undertakes no
obligation to update publicly or revise any forward-looking
statement, regardless of whether new information becomes available,
future developments occur or otherwise.
Company
Contacts:
Mark Donohue
Investor Relations and Corporate Communications
(215)
558-4526
www.impaxlabs.com
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SOURCE Impax Laboratories, Inc.