New Drug Approvals Archive

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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 (methylphenidate) FDA Approval History

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 (ibuprofen lysine) FDA Approval History

April 13

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 (naltrexone) FDA Approval History

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 (alglucosidase alfa) FDA Approval History

July 7

Daytrana (methylphenidate)

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

Daytrana (methylphenidate) FDA Approval History

October 13

Vivitrol (naltrexone)

New Indication Approved: October 12, 2010

Vivitrol (naltrexone) FDA Approval History

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