HAYWARD, Calif., July 5, 2017 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical
company, today announced it has received final U.S. Food and Drug
Administration ("FDA") approval on its Abbreviated New Drug
Application ("ANDA") for a generic version of Focalin
XR® (dexmethylphenidate hydrochloride) extended-release
capsules CII, 25 and 35 mg. Impax has immediately initiated
commercialization activities.
This approval and launch of the 25 and 35 mg strengths
complements the Company's commercialized generic portfolio of
Focalin XR products, which also includes strengths of 5, 10, 15, 20
and 30 mg capsules.
According to IMS Health, dexmethylphenidate hydrochloride
extended-release capsules, 25 and 35 mg, had U.S. brand and generic
sales of approximately $93 million
for the 12 months ending May 2017.
Dexmethylphenidate hydrochloride extended-release capsules are
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in patients aged 6 years and older.
IMPORTANT SAFETY INFORMATION
Dexmethylphenidate Hydrochloride Extended-Release Capsules
should be given cautiously to patients with a history of drug
dependence or alcoholism. Chronic abusive use can lead to marked
tolerance and psychological dependence, with varying degrees of
abnormal behavior.
Dexmethylphenidate Hydrochloride Extended-Release Capsules are
not for use in patients:
- With marked anxiety, tension, and agitation
- Known to be hypersensitive to methylphenidate, or other
components of the product.
- With glaucoma
- With motor tics or with a family history or diagnosis of
Tourette's syndrome
- During treatment with monoamine oxidase inhibitors, and also
within a minimum of 14 days following discontinuation of treatment
with a monoamine oxidase inhibitor
The following have been reported with use of
dexmethylphenidate hydrochloride and other stimulant
medicines.
Heart-related problems:
- sudden death in patients who have heart problems or heart
defects
- stroke and heart attack in adults
- increased blood pressure and heart rate
Mental (Psychiatric) problems:
All Patients
- new or worse behavior and thought problems
- new or worse bipolar illness
- new or worse aggressive behavior or hostility
Children and Teenagers
- new psychotic symptoms (such as hearing voices, believing
things that are not true, are suspicious) or new manic
symptoms
Circulation problems in fingers and toes [Peripheral
vasculopathy, including Raynaud's phenomenon]: fingers or toes may
feel numb, cool, painful, and/or may change color from pale, to
blue, to red.
Other serious side effects include:
- serious allergic reactions (symptoms can be difficulty
breathing, swelling of the face, neck and throat, rashes and hives,
fever)
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- painful and prolonged erections (priapism) have occurred with
methylphenidate.
- eyesight changes or blurred vision
Most common adverse reactions (at least 5% and twice the incidence
among placebo-treated patients) are dyspepsia, decreased appetite,
headache, and anxiety for pediatric patients and dry mouth,
dyspepsia, headache, and anxiety for adult patients.
For complete safety information and other important information
about this product please see the Full Prescribing Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit FDA MedWatch or call
1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax
Laboratories, Inc. at 1-877-994-6729.
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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/impax-announces-fda-approval-and-launch-of-additional-strengths-of-generic-focalin-xr-dexmethylphenidate-hydrochloride-extended-release-capsules-cii-300483625.html
SOURCE Impax Laboratories, Inc.