New Drug Approvals Archive
New Drug Approvals: April 2008
| April 4 | Rotarix (rotavirus vaccine, live attenuated) Date of Approval: April 3, 2008 Company: GlaxoSmithKline Treatment for Prevention of Rotavirus Gastroenteritis Rotarix 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 9 | U.S. Food and Drug Administration Approves Orencia (abatacept) for the Treatment of Moderate-to-severe Polyarticular Juvenile Idiopathic Arthritis in Patients Six Years and Older |
| April 11 | Lexiscan (regadenoson) Injection Date of Approval: April 10, 2008 Company: CV Therapeutics, Inc. Treatment for Pharmacologic Stress Agent in Radionuclide Myocardial Perfusion Imaging 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 16 | 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 16 | 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 Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults. Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease |
| April 23 | FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults |
| April 24 | 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 | FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis |
| April 25 | Relistor (methylnaltrexone bromide) Subcutaneous Injection Date of Approval: April 25, 2008 Company: Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Treatment for Opioid-Induced Constipation Relistor is a peripherally acting mu-opioid receptor antagonist indicated to treat opioid-induced constipation. Progenics and Wyeth Announce FDA Has Approved Relistor |
| April 29 | FDA Approves Second Improvement to Unigene's Calcitonin Manufacturing Process |
| April 30 | Sucampo Pharmaceuticals Obtains FDA Approval for Amitiza for the Treatment of Irritable Bowel Syndrome with Constipation in Adult Women |
| April 30 | FDA Approves Mixject, a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's Trelstar Depot and Trelstar LA |
New Drug Approvals Archive
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