BRIDGEWATER, N.J., Dec. 8, 2017 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL), a specialty
pharmaceutical company, today announced it has received tentative
U.S. Food and Drug Administration ("FDA") approval on its
Abbreviated New Drug Application ("ANDA") for a generic version of
Coreg CR® (carvedilol phosphate) extended-release
capsules, 10, 20, 40 and 80 mg. The Company's ANDA is eligible for
final approval upon the expiration of marketing exclusivity on
May 7, 2018.
Carvedilol phosphate extended-release capsules had U.S. brand
sales of approximately $206 million,
according to IMS Health for the 12 months ending October
2017.
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
the Impax Specialty Pharma division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform 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
the Company's operating results and financial condition; the
volatility of the market price of the Company's common stock; the
Company's ability to successfully develop and commercialize
pharmaceutical products in a timely manner; the impact of
competition; the effect of any manufacturing or quality control
problems; the Company's ability to manage its growth; risks
related to acquisitions of or investments in technologies, products
or businesses; risks relating to goodwill and intangibles; the
reduction 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 Company's ability to sustain
profitability and positive cash flows; the impact of any valuation
allowance on the Company's deferred tax assets; 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; the availability of
additional funds in the future; 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 to settle patent litigations, 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 Numient® (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, rebates, 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; changes in tax regulations;
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.
Contact:
Mark
Donohue
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
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SOURCE Impax Laboratories, Inc.