New Drug Approvals Archive

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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.

Rotarix (rotavirus vaccine, live attenuated) FDA Approval History

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.

Lexiscan (regadenoson) FDA Approval History

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.

Patanase (olopatadine hydrochloride) FDA Approval History

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 succinate and naproxen sodium) FDA Approval History

April 22

Cimzia (certolizumab pegol) Injection

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

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

Cimzia (certolizumab pegol) FDA Approval History

April 23

Vyvanse (lisdexamfetamine dimesylate)

Patient Population Altered: April 23, 2008

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

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.

Aplenzin (bupropion hydrobromide) FDA Approval History

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.

Relistor (methylnaltrexone bromide) FDA Approval History

May 13

Cimzia (certolizumab pegol)

New Indication Approved: May 13, 2009

Cimzia (certolizumab pegol) FDA Approval History

September 30

Cimzia (certolizumab pegol)

New Indication Approved: September 27, 2013

Cimzia (certolizumab pegol) FDA Approval History

October 18

Cimzia (certolizumab pegol)

New Indication Approved: October 17, 2013

Cimzia (certolizumab pegol) FDA Approval History

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