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Prasco Laboratories Launches Authorized Generic of Shire plce's Carbatrol(R)


1/12/2012 10:46:06 AM

CINCINNATI, Jan. 12, 2012 /PRNewswire/ -- Prasco® Laboratories announced today it has entered into an agreement with Shire (NASDAQ: SHPGY) for the distribution in the U.S. of theAuthorized Generic version of Carbatrol® (Carbamazepine) Extended-Release Capsules in 100 mg, 200 mg and 300 mg strengths.

Carbamazepine Extended-Release Capsules are AB-rated, therapeutically equivalent and substitutable for the brand Carbatrol®. The product will be distributed in the U.S. under the Prasco label. Financial terms of the agreement were not disclosed.

"We are pleased to provide Carbamazepine Extended-Release Capsules to pharmacists and consumers," said Prasco chief executive officer Christopher H. Arington. "As a Prasco Authorized Generic, Carbamazepine Extended-Release Capsules will provide patients with a therapeutically equivalent product to the brand."

Indications

Carbatrol is a medicine used to treat:

  • certain types of seizures (partial, tonic-clonic, mixed).
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbatrol is not a regular pain medicine and should not be used for aches or pains.

Important Safety Information

Do not stop taking Carbatrol without first talking to your doctor. Stopping Carbatrol suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

WARNING

SERIOUS SKIN REACTIONS

Carbatrol may cause rare but serious rashes that may lead to death. These serious skin reactions are more likely to happen within the first four months of Carbatrol treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent you may need a genetic blood test before you take Carbatrol to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

  • skin rash
  • hives
  • sores in your mouth
  • blistering or peeling of the skin

SERIOUS BLOOD PROBLEMS

Carbatrol may cause rare but serious blood problems. Symptoms may include:

  • fever, sore throat or other infections that come and go or do not go away
  • easy bruising
  • red or purple spots on your body
  • bleeding gums or nose bleeds
  • severe fatigue or weakness

Carbamazepine extended-release capsules, 100 mg, 200 mg and 300 mg, represent the latest product from Prasco in its expanding Authorized Generics portfolio. Carbatrol is registered in the United States Patent and Trademark Office. For additional important information, click here to see the Full Prescribing Information, INCLUDING BOXED WARNING, or visit www.prasco.com.

About Prasco Laboratories Prasco, the Authorized Generics company, is a privately-held pharmaceutical company located in Mason, Ohio that specializes in Authorized Generics. Prasco authorized Generics provide patients with the identical brand drug experience at a price that competes with generics. Prasco Authorized Generics also simplify interactions between pharmacists and consumers because they are identical to branded drugs. Moreover, Prasco Authorized Generics offer brand pharmaceutical companies a strategic lifecycle management solution. For more information, visit www.prasco.com.

About Carbatrol

Indications

Carbatrol is a medicine used to treat:

  • certain types of seizures (partial, tonic-clonic, mixed).
  • certain types of nerve pain (trigeminal and glossopharyngeal neuralgia).

Carbatrol is not a regular pain medicine and should not be used for aches or pains.

Additional Important Safety Information

Do not take Carbatrol if you:

  • Have a history of bone marrow depression.
  • Are allergic to carbamazepine or any of the ingredients in Carbatrol.
  • Take nefazodone.
  • Are allergic to antidepressant medications called tricyclic (TCAs).
  • Have taken a medicine called Monoamine Oxidase Inhibitor (MAOI) in the last 14 days.

Call your doctor right away at the first sign of a skin rash while taking Carbatrol.

Carbatrol may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempt to commit suicide; new or worse depression, anxiety or irritability; feeling agitated or restless; panic attacks; trouble sleeping; acting aggressive, being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; or other unusual changes in behavior or mood.

Tell your doctor right away if you become pregnant while taking Carbatrol. Carbatrol may harm your unborn baby and can pass into breast milk. You and your doctor should decide if you should take Carbatrol while you are pregnant or plan to breastfeed.

  • If you become pregnant while taking Carbatrol, talk to your doctor about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll- free number at 1-888-233-2334.

Carbatrol may make your birth control less effective. Discuss your birth control options with your doctor.

Tell your doctor if you have a history of seizures; a history of heart, blood problems, liver, or kidney problems; have any other medical conditions; or have previously started and stopped therapy with Carbatrol.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Carbatrol may cause serious side effects such as irregular heartbeat (such as pounding heartbeat or shortness of breath) and liver problems (such as yellowing of your skin).

The most common side effects of Carbatrol include dizziness, drowsiness, unsteadiness, nausea and vomiting.

Do not crush, chew or break Carbatrol capsules or the beads inside of the capsules.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Full Prescribing Information and Medication Guide, including Boxed WARNING regarding Serious Skin Reactions and Serious Blood Problems.

SOURCE Prasco Laboratories


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