HAYWARD, Calif., July 17, 2017 /PRNewswire/ -- Impax
Laboratories, Inc. (NASDAQ: IPXL), a specialty
pharmaceutical company, today announced it has received an AB
therapeutic equivalent rating and final U.S. Food and Drug
Administration ("FDA") approval on its Abbreviated New Drug
Application ("ANDA") for a generic version of Concerta®
(methylphenidate hydrochloride) Extended-Release tablets USP CII,
18, 27, 36 and 54 mg.
"Approval of our AB-rated generic version of Concerta further
demonstrates the capabilities of Impax's R&D organization,"
said Paul Bisaro, President and
Chief Executive Officer of Impax. "We are preparing for launch
including working to secure API quota and currently expect to
launch by the end of this year. As a result, we don't anticipate
sales of generic Concerta to meaningfully impact our earnings in
2017."
Methylphenidate hydrochloride extended-release tablets had U.S
sales of approximately $1.8 billion,
according to IMS Health for the 12 months ending May
2017.
Methylphenidate hydrochloride extended-release tablets, are
indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in children 6 years of age and older, adolescents,
and adults up to the age of 65.
IMPORTANT SAFETY INFORMATION
WARNING: DRUG
DEPENDENCE
See full prescribing information for complete boxed
warning.
|
Methylphenidate
hydrochloride extended-release tablets 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.
|
Methylphenidate hydrochloride extended-release tablets are not
for use in patients:
- With known hypersensitivity to the product
- With marked anxiety, tension, or agitation
- With glaucoma
- With tics or a family history or diagnosis of Tourette's
syndrome
- Currently using or within 2 weeks of using an MAO
inhibitor
The following have been reported with use of methylphenidate
HCl 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
Painful and prolonged erections (priapism)
Painful and
prolonged erections (priapism) have occurred with
methylphenidate.
Circulation problems in fingers and toes [Peripheral
vasculopathy, including Raynaud's phenomenon]:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue to red
Other serious side effects include:
- slowing of growth (height and weight) in children
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
- blockage of the esophagus, stomach, small or large intestine in
patients who already have a narrowing in any of these organs
The most common adverse reaction in double-blind clinical trials
(>5%) in children and adolescents was abdominal pain upper. The
most common adverse reactions in double-blind clinical trials
(>5%) in adult patients were decreased appetite, headache, dry
mouth, nausea, insomnia, anxiety, dizziness, weight decreased,
irritability, and hyperhidrosis. The most common adverse reactions
associated with discontinuation (≥1%) from either pediatric or
adult clinical trials were anxiety, irritability, insomnia, and
blood pressure increased.
For complete safety information and other important information
about this product please see the Full Prescribing Information
including the medication guide.
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
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SOURCE Impax Laboratories, Inc.