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 XR
IMPORTANT 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
- 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)
- 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