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Wednesday, November 9, 2011

September First Time Generic Drug Approval

Levetiracetam Extended-Release Tablets 500 mg and 750 mg
Approved: September 12, 2011 - Actavis Elizabeth LLC; Par Pharmaceutical, Inc.; Apotex, Watson Laboratories, Inc.; Mutual Pharmaceutical Company, Inc.; Teva Pharmaceuticals USA
Generic for: Keppra XR



Levetiracetam is an anti-epileptic drug.
Levetiracetam is used to treat partial onset seizures in adults and children who are at least 4 years old.
Levetiracetam is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.
Do not stop taking levetiracetam without first talking to your doctor, even if you feel better. If you stop taking levetiracetam suddenly, you may have increased seizures. Tell your doctor if you have new or worsening seizures.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Carry an ID card or wear a medical alert bracelet stating that you are taking levetiracetam, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking levetiracetam. Levetiracetam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
You should not use this medication if you are allergic to levetiracetam.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.
You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
FDA pregnancy category C. It is not known whether levetiracetam is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Levetiracetam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

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