New Drug Approvals Archive
New Drug Approvals: April 2007
| April 2 | Janumet (sitagliptin and metformin) Tablets Date of Approval: March 30, 2007 Company: Merck & Co., Inc. Treatment for Diabetes Mellitus Type II Janumet is a combination of the oral antihyperglycemic drugs sitagliptin and metformin indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet |
| April 2 | FDA Approves Rhophylac for the Treatment of Immune Thrombocytopenic Purpura (ITP) |
| April 2 | FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix |
| April 3 | Managing Diabetes is Now Simpler and More Convenient with New Premixed Insulin Analogue |
| April 4 | Pharmacyclics' Xcytrin New Drug Application for Treatment of Lung Cancer Brain Metastases to Be Filed Over Protest |
| April 6 | FDA approves Cangene's HepaGam B for a Second Indication; for Use in Hepatitis B-positive Liver Transplant Recipients |
| April 6 | Abbott Announces FDA Approval of a New Coated Niaspan Tablet |
| April 6 | FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in |
| April 12 | Lupin Receives US FDA Approval for Novel Formulation of Suprax Suspension |
| April 13 | Altabax (retapamulin) Ointment Date of Approval: April 12, 2007 Company: GlaxoSmithKline Treatment for Impetigo Altabax is a topical antibiotic indicated for the treatment of impetigo in adults and children aged 9 months and older. GSK Announces FDA Approval of Altabax (Retapamulin Ointment), 1% |
| April 13 | FDA Approves New Dose of Risperdal Consta for Schizophrenia Treatment |
| April 17 | Reclast (zoledronic acid) Infusion - formerly Aclasta Date of Approval: April 16, 2007 Company: Novartis Treatment for Paget's Disease, Prevention of Osteoporosis Reclast, a bisphosphonate, is the first approved treatment for Paget's disease patients to be given as a single-dose infusion compared to current oral therapies that must be taken daily for up to six months. Reclast has also been approved as the first and only once-yearly medicine for postmenopausal osteoporosis. Reclast Receives US Approval as a Highly Effective Treatment for Patients with Paget's Disease of the Bone |
| April 17 | FDA Approves New Actonel Dose to Treat and Prevent Postmenopausal Osteoporosis |
| April 17 | Influenza Virus Vaccine, H5N1 () Injection Date of Approval: April 17, 2007 Company: Sanofi Pasteur Inc. Treatment for Prevention of H5N1 Influenza (Avian Influenza) Influenza Virus Vaccine, H5N1 is an inactivated influenza virus vaccine indicated for immunization of persons 18 through 64 years of age who are at increased risk of exposure to the H5N1 influenza virus, commonly referred to as avian influenza or "bird flu." FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1 |
| April 20 | FDA Grants Full Approval for DepoCyt for the Treatment of Lymphomatous Meningitis |
| April 24 | FDA Approves Alpharma's Kadian New 10mg Strength |
| April 24 | FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia |
| April 25 | New Indication for Singulair (montelukast sodium) Approved to Prevent Exercise-induced Bronchoconstriction |
| April 25 | FDA Approves Labeling Update for Orencia (abatacept) to Inhibit Structural Joint Damage in Adults with Moderate to Severe Rheumatoid Arthritis |
| April 27 | Invega (paliperidone) Extended-Release Tablets Date of Approval: December 19, 2006 Company: Janssen, L.P. Treatment for Schizophrenia Invega is a once-daily oral atypical antipsychotic indicated for the treatment of schizophrenia. FDA Approves Invega for Long-Term Maintenance Treatment of Schizophrenia |
| April 29 | Veramyst (fluticasone furoate) Nasal Spray Date of Approval: April 27, 2007 Company: GlaxoSmithKline Treatment for Allergy Symptoms Veramyst is an intranasal corticosteroid administered once-daily for the treatment of seasonal and year- round allergy symptoms in adults and children two years of age and older. FDA Approves Once-Daily Veramyst (fluticasone furoate) Nasal Spray for Treatment of Seasonal and Year-Round Allergy Symptoms in Adults and Children as Young as Two Years |
| April 29 | AzaSite (azithromycin) Ophthalmic Solution Date of Approval: April 27, 2007 Company: InSite Vision Incorporated Treatment for Bacterial Conjunctivitis AzaSite is an ophthalmic formulation of the well-known, broad-spectrum antibiotic azithromycin indicated for the treatment of bacterial conjunctivitis. Inspire Announces FDA Approval Of AzaSite |
| April 30 | FDA Approves Lantus SoloStar - A New Prefilled Disposable Insulin Pen For Use With Lantus In People With Type 1 And Type 2 Diabetes |
| April 30 | Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) Tablets Receives Two New FDA Approvals |
| April 30 | Humate-P Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery |
New Drug Approvals Archive
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