New Drug Approvals Archive - January 2008
See also: New Indications and Dosage Forms for January 2008
January 2008
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.
Flo-Pred (prednisolone acetate) Oral Suspension
Date of Approval: January 17, 2008
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Asthma, Inflammatory Conditions
Marketing Status: Discontinued
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.
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.
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) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets
Date of Approval: January 18, 2008
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Blood Pressure
Tekturna HCT (aliskiren and hydrochlorothiazide) is a single-tablet combination therapy for the treatment of high blood pressure.
Moxatag (amoxicillin) Extended Release Tablets
Date of Approval: January 23, 2008
Company: Pragma
Treatment for: Tonsillitis/Pharyngitis
Marketing Status: Discontinued
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).
Accretropin (somatropin (rDNA origin)) Subcutaneous Injection
Date of Approval: January 23, 2008
Company: Emergent
Treatment for: Pediatric Growth Hormone Deficiency, Turner Syndrome
Marketing Status: Discontinued
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.
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