New Drug Approvals Archive

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January 2008

January 2

Glumetza (metformin extended release)

New Dosage Form Approved: December 4, 2007

Glumetza (metformin extended release) FDA Approval History

January 3

Vyvanse (lisdexamfetamine dimesylate)

New Dosage Form Approved: December 10, 2007

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

January 8

Cialis (tadalafil)

New Dosage Regimen: January 7, 2008

January 15

Tysabri (natalizumab)

New Indication Approved: January 14, 2008

Tysabri (natalizumab) FDA Approval History

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 (ciclesonide) FDA Approval History

January 17

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.

Flo-Pred (prednisolone acetate) FDA Approval History

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.

Recothrom (Thrombin, topical (Recombinant)) FDA Approval History

January 22

Humira (adalimumab)

New Indication Approved: January 18, 2008

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) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Intelence (etravirine) FDA Approval History

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 (aliskiren and hydrochlorothiazide) FDA Approval History

January 23

Mycamine (micafungin sodium)

New Indication Approved: January 22, 2008

Mycamine (micafungin sodium) FDA Approval History

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).

Moxatag (amoxicillin) FDA Approval History

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.

Accretropin (somatropin (rDNA origin)) FDA Approval History

July 21

Tekturna HCT (aliskiren and hydrochlorothiazide)

New Indication Approved: July 16, 2009

Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

December 2

Intelence (etravirine)

Labeling Revision Approved: November 24, 2009

Intelence (etravirine) FDA Approval History

January 3

Intelence (etravirine)

New Formulation Approved: December 22, 2010

Intelence (etravirine) FDA Approval History

March 27

Intelence (etravirine)

Patient Population Altered: March 26, 2012

Intelence (etravirine) FDA Approval History

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