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Impax Announces FDA Approval and Launch of Additional Strengths of Generic Focalin XR® (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII

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.


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...