New Drug Approvals Archive - January 2008

Glumetza (metformin extended release)

New Dosage Form Approved: December 4, 2007

• Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza

Glumetza (metformin extended release) FDA Approval History

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

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

Cialis (tadalafil)

New Dosage Regimen: January 7, 2008

• FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction

Tysabri (natalizumab)

New Indication Approved: January 14, 2008

• FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

Tysabri (natalizumab) FDA Approval History

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

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.

• Taro Receives FDA Approval of New Drug Application for Flo-Pred (Prednisolone Acetate Oral Suspension)

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.

• FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant)

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

Humira (adalimumab)

New Indication Approved: January 18, 2008

• Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis

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.

• FDA Approves Intelence (etravirine) for HIV Combination Therapy

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.

• Tekturna HCT, a Single-Tablet Combination of Tekturna and a Diuretic, Receives US Approval for Treatment of High Blood Pressure

Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

Mycamine (micafungin sodium)

New Indication Approved: January 22, 2008

• FDA Approves Additional Indication for Astellas' Mycamine

Mycamine (micafungin sodium) 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).

• FDA Approves MiddleBrook's Moxatag - Amoxicillin PULSYS - for Pharyngitis/Tonsillitis in Adolescents and Adults

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.

• Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration

Accretropin (somatropin (rDNA origin)) FDA Approval History

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

Tekturna HCT (aliskiren and hydrochlorothiazide) FDA Approval History

Intelence (etravirine)

Labeling Revision Approved: November 24, 2009

• U.S. Food And Drug Administration (FDA) Grants Traditional Approval for Intelence (etravirine)

Intelence (etravirine) FDA Approval History

Intelence (etravirine)

New Formulation Approved: December 22, 2010

• FDA Approves New Dosage Strength for Intelence

Intelence (etravirine) FDA Approval History

Intelence (etravirine)

Patient Population Altered: March 26, 2012

• FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review

Intelence (etravirine) FDA Approval History