ADDERALL® (mixed salts of a single-entity amphetamine product) Supply Clarification

PHILADELPHIA, Dec. 1, 2011 /PRNewswire/ -- Shire plc, the global specialty biopharmaceutical company, responds to questions about reports of a supply shortage of ADDERALL® (mixed salts of a single-entity amphetamine product) Tablets, CII. ADDERALL® is an immediate release formulation and is sometimes referred to as "ADDERALL IR." While Shire is aware of the reports of the supply shortage, Shire cannot provide additional information because Shire does not own, manufacture or distribute the medication. Shire suggests that questions about the supply shortage be directed to the companies that manufacture and/or distribute ADDERALL IR.

Shire developed ADDERALL IR, and the FDA approved ADDERALL( )IR as a treatment for ADHD in children in 1996. Shire divested ADDERALL( )IR in 2007 and no longer owns, manufactures, or distributes ADDERALL IR or any of its generic forms. Several pharmaceutical companies currently manufacture and distribute generic forms of ADDERALL IR. According to the FDA, those companies are Sandoz, CorePharma, and Teva. Additional information about the supply shortage of ADDERALL IR is posted on the FDA Drug Shortages website: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Shire also developed and currently manufactures ADDERALL XR® (mixed salts of a single-entity amphetamine product) Capsules, CII, an extended release capsule formulation that was first approved by FDA in 2001 as a treatment for ADHD in children. ADDERALL XR® is available at pharmacies and current inventories of all strengths of ADDERALL XR® are sufficient to meet patient demand.

ADDERALL XR is a stimulant medication and federally controlled substance (CII) because it can be abused or lead to dependence. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

INDICATION

ADDERALL XR is a prescription medicine for the treatment of ADHD in children ages 6 to 17 and adults. ADDERALL XR should be used as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION

    ADDERALL XR is a federally controlled
     substance (CII) because it can be
     abused or lead to dependence. Keep
     in a safe place to prevent misuse
     and abuse. Selling or giving away
     ADDERALL XR may harm others and is
     illegal.  ADDERALL XR is a
     stimulant.  Misuse of stimulants may
     cause sudden death and serious heart
     problems.
    -------------------------------------

    --  ADDERALL XR should not be taken by patients who have:Heart disease or
        hardening of the arteries,  moderate to severe high blood pressure, 
        overactive thyroid gland (hyperthyroidism),  glaucoma, agitated states,
        a history of drug abuse, taken an anti-depression medicine called a
        monoamine oxidase inhibitor (MAOI) within the last 14 days, or
        sensitivity to, are allergic to, or had a reaction to other stimulant
        medicines.

    --  ADDERALL XR is a stimulant medicine. The following have been reported
        with use of stimulant medicines.