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New Drug Approvals Archive

New Drug Approvals: April 2006

April 6
Daytrana (methylphenidate) Transdermal System - formerly MTS

Date of Approval: April 6, 2006

Company: Shire Pharmaceuticals Group plc / Noven Pharmaceuticals, Inc.

Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Daytrana is a once daily transdermal patch formulation of methylphenidate indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Daytrana Approved - Shire plc - Treatment for Attention Deficit Hyperactivity Disorder
 
April 13
NeoProfen (ibuprofen lysine) Injection

Date of Approval: April 13, 2006

Company: Farmacon-IL, LLC

Treatment for Patent Ductus Arteriosus

NeoProfen is an intravenous formulation of ibuprofen lysine indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants, who are no more than 32 weeks gestational age when usual medical management is ineffective.

NeoProfen Approved - Farmacon-IL, LLC - Treatment for Patent Ductus Arteriosus
 
April 13
Vivitrol (naltrexone) Long-Acting Injection - formerly Vivitrex

Company: Alkermes, Inc.

Treatment for Alcohol Dependence

Vivitrol Approved - Alkermes Inc. and Cephalon Inc - Treatment for Alcohol Dependence
 
April 28
Myozyme (alglucosidase alfa)

Date of Approval: April 28, 2006

Company: Genzyme Corp.

Treatment for Pompe disease

Myozyme is a recombinant formulation of the human enzyme acid alpha-glucosidase (GAA) indicated for use in patients with Pompe disease (GAA deficiency), a debilitating and often fatal muscle disorder.

Myozyme Approved - Genzyme Corp. - Treatment for Pompe Disease
 

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