New Drug Approvals Archive
New Drug Approvals: January 2008
| January 2 | Glumetza (metformin extended release)
New Dosage Form Approved: December 4, 2007 Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza |
| January 3 | Vyvanse (lisdexamfetamine dimesylate)
New Dosage Form Approved: December 10, 2007 FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients |
| January 8 | Cialis (tadalafil)
New Dosage Regimen: January 7, 2008 FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction |
| January 15 | Tysabri (natalizumab)
New Indication Approved: January 14, 2008 FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease |
| January 10 | 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 22 | Humira (adalimumab)
New Indication Approved: January 18, 2008 Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis |
| January 18 | 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 18 | 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 23 | 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 23 | 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 |
| July 21 | Tekturna HCT (aliskiren and hydrochlorothiazide)
New Indication Approved: July 16, 2009 FDA Approves Tekturna HCT as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent |
New Drug Approvals Archive
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