New Drug Approvals Archive
New Drug Approvals: January 2008
| January 2 | Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza |
| January 3 | Sciele Pharma Announces FDA Approval of New Sular Formulation |
| January 3 | FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients |
| January 8 | FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction |
| January 10 | OMRIX Biopharmaceuticals Receives FDA Approval for General Hemostasis in Surgery Indication for Evicel Liquid Fibrin Sealant (Human) |
| January 14 | King Pharmaceuticals Reports FDA Approval of Revised Labeling Regarding Purity of Thrombin-JMI |
| January 15 | FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease |
| January 16 | Alvesco (ciclesonide) Inhalation Aerosol Date of Approval: January 10, 2008 Company: Nycomed Treatment for Asthma Alvesco (ciclesonide) is an inhaled corticosteroid indicated for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. Alvesco Gains FDA Approval for the U.S. Market |
| January 17 | Flo-Pred (prednisolone acetate) Oral Suspension Date of Approval: January 17, 2008 Company: Taro Pharmaceutical Industries Ltd. Treatment for Anti-inflammatory, Asthma Flo-Pred (prednisolone acetate) is a cherry flavored oral liquid corticosteroid formulation which does not require refrigeration and does not require shaking prior to use. Flo-Pred is an anti-inflammatory agent for the treatment of asthma, certain allergic and dermatologic conditions, as well as a variety of other indications. Taro Receives FDA Approval of New Drug Application for Flo-Pred (Prednisolone Acetate Oral Suspension) |
| January 17 | Recothrom (Thrombin, topical (Recombinant)) - formerly rhThrombin Date of Approval: January 17, 2008 Company: ZymoGenetics, Inc. Treatment for Hemostasis During Surgery Recothrom is a recombinant form of human thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP. FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant) |
| January 18 | Welchol (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes |
| January 22 | Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis |
| January 22 | Intelence (etravirine) Tablets - formerly TMC125 Date of Approval: January 18, 2008 Company: Tibotec Pharmaceuticals Ltd. Treatment for HIV Infection Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients. FDA Approves Intelence (etravirine) for HIV Combination Therapy |
| January 22 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets Date of Approval: January 18, 2008 Company: Novartis Pharmaceuticals Corporation Treatment for Hypertension Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure. Tekturna HCT, a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure |
| January 22 | FDA Approves Labeling Change for Non-Drowsy Claritin |
| January 23 | FDA Approves Additional Indication for Astellas' Mycamine |
| January 24 | Moxatag (amoxicillin) Extended Release Tablets - formerly Amoxicillin PULSYS Date of Approval: January 23, 2008 Company: MiddleBrook Pharmaceuticals, Inc. Treatment for Tonsillitis/Pharyngitis Moxatag is a once-daily extended-release formulation of the penicillin antibiotic amoxicillin indicated for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat). FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults |
| January 25 | ImaRx Therapeutics Receives Urokinase Lot Release Approval With Extended Expiration Dating |
| January 25 | Accretropin (somatropin (rDNA origin)) Subcutaneous Injection Date of Approval: January 23, 2008 Company: Cangene Treatment for Pediatric Growth Hormone Deficiency, Turner's Syndrome Accretropin (somatropin (rDNA origin)) is recombinant human growth hormone indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed. Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration |
| January 29 | FDA Approves Emend (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy, for Use in Combination with Other Antiemetics for Prevention of Nausea and Vomiting Caused by Chemotherapy |
New Drug Approvals Archive
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