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New Drug Approvals Archive - April 2008

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 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. CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(regadenoson) Injection 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. Alcon's Patanase Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms Patanase (olopatadine hydrochloride) FDA Approval History
April 15	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. Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDA for 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 Approved in the US for the Treatment of Moderate to Severe Crohn's Disease Cimzia (certolizumab pegol) FDA Approval History
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 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. Biovail Receives FDA Approval for Aplenzin (BVF-033) Aplenzin (bupropion hydrobromide) FDA Approval History
April 25	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. Progenics and Wyeth Announce FDA Has Approved Relistor Relistor (methylnaltrexone bromide) FDA Approval History
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 Cimzia (certolizumab pegol) FDA Approval History
September 30	Cimzia (certolizumab pegol) New Indication Approved: September 27, 2013 FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis Cimzia (certolizumab pegol) FDA Approval History
October 18	Cimzia (certolizumab pegol) New Indication Approved: October 17, 2013 Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis Cimzia (certolizumab pegol) FDA Approval History
May 15	Treximet (sumatriptan succinate and naproxen sodium) Patient Population Altered: May 15, 2015 FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients Treximet (sumatriptan succinate and naproxen sodium) FDA Approval History
July 19	Relistor (methylnaltrexone bromide) New Dosage Form Approved: July 19, 2016 Valeant and Progenics Announce FDA Approves Relistor Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain Relistor (methylnaltrexone bromide) FDA Approval History

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