New Drug Approvals Archive

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

Daytrana (methylphenidate) FDA Approval History

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

NeoProfen (ibuprofen lysine) FDA Approval History

Vivitrol (naltrexone) Long-Acting Injection - formerly Vivitrex

Date of Approval: April 13, 2006
Company: Alkermes, Inc.
Treatment for: Alcohol Dependence

Vivitrol (naltrexone) is is an opioid antagonist indicated for the treatment of alcohol dependence and opioid dependence.

• Vivitrol Approved - Alkermes Inc. and Cephalon Inc - Treatment for Alcohol Dependence

Vivitrol (naltrexone) FDA Approval History

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

Myozyme (alglucosidase alfa) FDA Approval History

Daytrana (methylphenidate)

Patient Population Altered: June 29, 2010
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

• FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents

Daytrana (methylphenidate) FDA Approval History

Vivitrol (naltrexone)

New Indication Approved: October 12, 2010

• FDA Approves Vivitrol to Treat Opioid-dependent Patients

Vivitrol (naltrexone) FDA Approval History