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New Drug Approvals Archive - 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.

Read more: Rotarix (rotavirus vaccine, live attenuated) FDA Approval History

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.

Read more: Lexiscan (regadenoson) FDA Approval History

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.

Read more: Patanase (olopatadine hydrochloride) FDA Approval History

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.

Read more: Treximet (sumatriptan succinate and naproxen sodium) FDA Approval History

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, and plaque psoriasis.

Read more: Cimzia (certolizumab pegol) FDA Approval History

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.

Read more: Aplenzin (bupropion hydrobromide) FDA Approval History

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.

Read more: Relistor (methylnaltrexone bromide) FDA Approval History

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