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Pfizer Inc. (NYSE: PFE) today announced that it has completed its acquisition of NextWave Pharmaceuticals, Inc., a privately held, specialty pharmaceutical company focused on the development and commercialization of products for the treatment of attention deficit hyperactivity disorder (ADHD).
Upon the closing of the transaction, Pfizer now holds exclusive North American commercialization rights to Quillivant XR™ (methylphenidate hydrochloride) for extended-release oral suspension, CII, the first once-daily liquid medication approved in the U.S. for the treatment of ADHD. Quillivant XR received approval from the U.S. Food and Drug Administration on September 27, 2012, and is expected to be available in pharmacies in the U.S. in January 2013.
About Quillivant XRIMPORTANT SAFETY INFORMATIONQuillivant XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Quillivant XR in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR may harm others and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Quillivant XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
Heart-related problems have been reported with methylphenidate hydrochloride and other stimulant medications:
Sudden death in patients who have heart problems or heart defects
Stroke and heart attack in adults
Increased blood pressure and heart rate
Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with QUILLIVANT XR.
Mental (psychiatric) problems can be caused or worsened by methylphenidate hydrochloride and other stimulant medications:
New or worse behavior or thought problems
New or worsening bipolar symptoms
New or worsening psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious)
Call your doctor right away if you or your child have any heart-related symptoms such as chest pain, shortness of breath or fainting or new or worsening mental (psychiatric) symptoms or new manic symptoms while taking Quillivant XR.
Quillivant XR may not be right for you. Tell your doctor if:
You or your child have heart problems, heart defects, or high blood pressure
You or your child have mental problems including psychosis (hearing voices, believing things that are not true, suspicious), mania, bipolar illness, or depression or about a family history of suicide, bipolar illness or depression
You are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
You are breastfeeding or plan to breast feed. Quillivant XR passes into your breast milk. You and your doctor should decide if you will take Quillivant XR or breast feed
serious side effects of Quillivant XR are heart-related problems and mental problems, as well as slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking QUILLIVANT XR. QUILLIVANT XR treatment may be stopped if a problem is found during these check-ups.
Common side effects include:
Increased blood pressure
Fast heart beat
Talk to your doctor if you or your child have side effects that are bothersome or do not go away.