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Actionable news in IPXL: Impax Laboratories, Inc.,

Impax Announces FDA Approval of its AB Rated Generic Concerta® (Methylphenidate Hydrochloride) Extended-Release Tablets CII

"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

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...


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