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New Drug Approvals Archive - April 2008

See also: New Indications and Dosage Forms for April 2008

April 2008

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.

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.

Treximet (sumatriptan succinate and naproxen sodium) Tablets - formerly Trexima

Date of Approval: April 15, 2008
Company: Pernix Therapeutics Holdings, 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.

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.

Cimzia (certolizumab pegol) Injection

Date of Approval: April 22, 2008
Company: UCB, Inc.
Treatment for: Crohn's Disease -- Acute, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis

Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.

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.

Relistor (methylnaltrexone bromide) Tablets and Subcutaneous Injection

Date of Approval: April 25, 2008
Company: Salix Pharmaceuticals, Inc.
Treatment for: Constipation

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

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