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New Drug Approvals Archive - 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.

Read more: Alvesco (ciclesonide) FDA Approval History

Flo-Pred (prednisolone acetate) Oral Suspension

Date of Approval: January 17, 2008
Company: Taro Pharmaceutical Industries Ltd.
Treatment for: Asthma, Anti-inflammatory

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.

Read more: Flo-Pred (prednisolone acetate) FDA Approval History

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.

Read more: Recothrom (Thrombin, topical (Recombinant)) FDA Approval History

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.

Read more: Intelence (etravirine) FDA Approval History

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.

Read more: Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

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).

Read more: Moxatag (amoxicillin) FDA Approval History

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.

Read more: Accretropin (somatropin (rDNA origin)) FDA Approval History

Intelence (etravirine)

New Formulation Approved: December 22, 2010

Read more: Intelence (etravirine) FDA Approval History

New Drug Approvals Archive