New Drug Approvals Archive

New Drug Approvals: April 2008

April 3
Rotarix (rotavirus vaccine, live attenuated) Oral Suspension

Date of Approval: April 3, 2008

Company: GlaxoSmithKline

Treatment for: Prevention of Rotavirus Gastroenteritis

Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.

FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus
 
April 10
Lexiscan (regadenoson) Injection

Date of Approval: April 10, 2008

Company: CV Therapeutics, Inc.

Treatment for: Diagnostic

Lexiscan (regadenoson) is an A2A adenosine receptor agonist indicated for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI), a test that detects and characterizes coronary artery disease, in patients unable to undergo adequate exercise stress.

CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection
 
April 15
Patanase (olopatadine hydrochloride) Nasal Spray

Date of Approval: April 15, 2008

Company: Alcon, Inc.

Treatment for: Allergic Rhinitis

Patanase (olopatadine) is an antihistamine nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents twelve years of age and older.

Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms
 
April 15
Treximet (sumatriptan succinate and naproxen sodium) Tablets - formerly Trexima

Date of Approval: April 15, 2008

Company: Pozen Inc.

Treatment for: Migraine

Treximet is a combination of sumatriptan (a migraine-specific triptan) and naproxen (an anti-inflammatory pain reliever) in a single tablet for the acute treatment of migraine.

Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for Acute Treatment of Migraine
 
April 22
Cimzia (certolizumab pegol) Injection

Date of Approval: April 22, 2008

Company: UCB, Inc.

Treatment for: Crohn's Disease -- Acute, Rheumatoid Arthritis

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease and rheumatoid arthritis in adults.

Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease
 
April 23
Vyvanse (lisdexamfetamine dimesylate)

Patient Population Altered: April 23, 2008

FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
 
April 23
Aplenzin (bupropion hydrobromide) Extended-Release Tablets - formerly BVF-033

Date of Approval: April 23, 2008

Company: Biovail Corporation

Treatment for: Depression

Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.

Biovail Receives FDA Approval for Aplenzin (BVF-033)
 
April 25
Relistor (methylnaltrexone bromide) Subcutaneous Injection

Date of Approval: April 25, 2008

Company: Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals

Treatment for: Constipation

Relistor (methylnaltrexone) is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation.

Progenics and Wyeth Announce FDA Has Approved Relistor
 
May 13
Cimzia (certolizumab pegol)

New Indication Approved: May 13, 2009

UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
 

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