AS RELEASED 6.28.16
Prasco Expands Its Portfolio Through Acquisition of Teva’s Authorized Generic of Adderall XR® (Mixed Salts of a Single-Entity Amphetamine Product) Extended Release Capsules, CII
Cincinnati, OH, June 28, 2016/PRNewswire/ — Prasco Laboratories (“Prasco”) today announced that it has entered into agreements with Teva Pharmaceutical Industries Ltd. (Teva) and Shire LLC, an indirect subsidiary of Shire plc, to acquire the rights to distribute Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended Release Capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, the Authorized Generic (AG) version of Adderall XR® Extended Release Capsules, CII. As a result of this acquisition, Prasco will market an AG version of Adderall XR Capsules, CII in the United States that is therapeutically equivalent and substitutable for prescriptions written for Adderall XR, a CNS stimulant that is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).
The Authorized Generic of Adderall XR is being divested by Teva as a precondition to its pending acquisition of Allergan’s generics business. Upon closing of its transaction with Teva, Prasco will immediately take over the distribution of the product, providing a seamless transition for both customers and patients.
“We are pleased to offer consumers an Authorized Generic of Adderall XR, thus allowing physicians, pharmacists, and consumers to experience product continuity between the brand and Prasco’s therapeutically-equivalent AG version of Adderall XR,” said Prasco chief executive officer, Chris Arington.
“Prasco continually looks for opportunities to expand its product portfolio, and this agreement represents our strategy of growth through acquisition,” stated Jonathan Lapps, Prasco senior vice president of business development. “Our existing business platform and successful experience with more than 40 brand company partners speaks to Prasco’s prominence as the premier AG partner.”
As the leader in the Authorized Generics business, Prasco has now brought more than 75 AG products to market since 2004 and has more AG partners than any other company in the U.S. Authorized Generic products can benefit multiple members of the marketplace by helping enhance access to treatment options.
About Adderall XR®
Adderall XR® is a once daily extended-release, single-entity amphetamine product. Amphetamine and dextroamphetamine are central nervous system stimulants that affect chemicals in the brain and nerves that contribute to hyperactivity and impulse control. The product has a boxed warning because amphetamines have a high potential for abuse. In addition, prolonged administration may lead to dependence and misuse of amphetamines may cause sudden death and serious cardiovascular adverse reactions.
Important Safety Information
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules administration is contraindicated in patients with the following conditions:
• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., anaphylaxis, angioedema, serious skin rashes)
• Glaucoma • Agitated states
• History of drug abuse
• During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result)
Warnings and Precautions
• Serious Cardiovascular Events: Sudden death has been reported with usual doses of CNS stimulants in children and adolescents with structural cardiac abnormalities or other serious heart problems; sudden death, stroke, and myocardial infarction have been reported in adults taking CNS stimulants at usual doses. Stimulant drugs should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
• Increase in Blood Pressure: Monitor blood pressure and pulse at appropriate intervals. Use with caution in patients for whom blood pressure increases may be problematic.
• Psychiatric Adverse Events: Stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stimulant use. Monitor for aggressive behavior.
• Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals.
• Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures.
• Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
• Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Tics: Stimulants may exacerbate tics. Evaluate for tics and Tourette’s syndrome prior to stimulant administration.
• Children (ages 6 to 12): Most common adverse reactions (= 5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
• Adolescents (ages 13 to 17): Most common adverse reactions (= 5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
• Adults: Most common adverse reactions (= 5% and with a higher incidence than on placebo) were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.
About Prasco Laboratories
Prasco, the Authorized Generic Company, is a privately held healthcare company located in Mason, Ohio. As the acknowledged category leader, Prasco has more Authorized Generic partnerships than any other company. Established brand companies rely on Prasco to bring their brand products to the generic marketplace as Authorized Generics, which offers alternatives to consumers and pharmacists. For more information, visit www.prasco.com.
ADDERALL XR® is a registered trademark of Shire LLC.