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
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:
- 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:
- 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.
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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.
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SOURCE Impax Laboratories, Inc.