Impax Receives FDA Approval for Generic Version of Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, CII
OREANDA-NEWS. Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for 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.
"With this approval, we are now in a position to provide our customers a continuity in supply of generic Adderall XR as we transition from our current inventory of the authorized generic version to supply from our ANDA product," said Fred Wilkinson, President and Chief Executive Officer of Impax. "We anticipate that we will complete this transition during the second quarter of 2016 and now have the opportunity to maximize the value from this important product."
Mr. Wilkinson concluded, "The approvals of our generic Adderall XR application and the mid-January approval of EMVERM™ (mebendazole) extend these key franchises, while also providing additional opportunities to pursue growth within these product segments."
According to IMS Health (NSP), U.S. brand and generic sales of mixed amphetamine sales capsules, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg were approximately $1.8 billion for the 12 months ending in November 2015.
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). 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. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
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)
- 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 Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through its Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platforms and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments.
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