IMPAX Labs Announces FDA Approval Of Its AB Rated Generic Concerta (Methylphenidate Hydrochloride) Extended-Release Tablets CII
Published: Jul 17, 2017
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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SOURCE Impax Laboratories, Inc.