New Drug Approvals Archive
New Drug Approvals: August 2009
| August 3 | Invega (paliperidone)
New Dosage Form Approved: July 31, 2009 FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia |
| August 3 | Avastin (bevacizumab)
New Indication Approved: July 31, 2009 FDA Approves Avastin for the Most Common Type of Kidney Cancer |
| August 3 | Livalo (pitavastatin) Tablets Date of Approval: August 3, 2009 Company: Kowa Company, Ltd. Treatment for: High Cholesterol Livalo (pitavastatin) is an HMG CoA reductase inhibitor indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia. FDA Approves Livalo for Primary Hypercholesterolemia and Combined Dyslipidemia |
| August 6 | Invega (paliperidone)
New Indication Approved: July 31, 2009 Invega Approved as the First and Only Treatment for Schizoaffective Disorder |
| August 13 | Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules Date of Approval: August 13, 2009 Company: King Pharmaceuticals , Inc. Treatment for: Pain Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain. FDA Approves Embeda For Management of Moderate to Severe Chronic Pain |
| August 13 | Saphris (asenapine) Sublingual Tablets Date of Approval: August 13, 2009 Company: Schering-Plough Corporation Treatment for: Schizophrenia, Bipolar Disorder Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder. Schering-Plough Announces FDA Approval of Saphris (asenapine) |
| August 14 | Extavia (interferon beta-1b) Date of Approval: August 14, 2009 Treatment for: Multiple Sclerosis Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients. US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease |
| August 19 | Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection Date of Approval: August 19, 2009 Company: GlaxoSmithKline Treatment for: Haemophilus influenzae Prophylaxis Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday). FDA Approves GSK's Hib Vaccine, Hiberix |
| August 21 | Sabril (vigabatrin) Tablets and Oral Solution Date of Approval: August 21, 2009 Company: Lundbeck Inc. Treatment for: Epilepsy, Seizures Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures. Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies |
| August 25 | Xyzal (levocetirizine dihydrochloride)
Patient Population Altered: August 21, 2009 FDA Approves Xyzal For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria |
| August 27 | Zenpep (pancrelipase) Capsules - formerly Zentase Date of Approval: August 27, 2009 Company: Eurand Pharmaceuticals Ltd. Treatment for: Pancreatic Exocrine Dysfunction Zenpep (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions. Eurand Granted FDA Approval for Zenpep |
| August 31 | Valcyte (valganciclovir)
New Dosage Form Approved: August 28, 2009 FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants |
New Drug Approvals Archive
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