New Drug Approvals Archive

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June 2005

June 3

Revatio (sildenafil citrate)

Date of Approval: June 3, 2005
Company: Pfizer Inc.
Treatment for: Pulmonary Hypertension

Revatio (sildenafil) is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension.

Revatio (sildenafil citrate) FDA Approval History

June 3

Glumetza (metformin extended release) Tablets

Date of Approval: June 3, 2005
Company: Biovail Corporation/Depomed, Inc.
Treatment for: Diabetes Type 2

Glumetza (metformin extended-release) is a once-daily oral antihyperglycemic formulation indicated for the treatment of type 2 diabetes.

Glumetza (metformin extended release) FDA Approval History

June 10

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap))

Date of Approval: June 10, 2005
Company: Aventis Pasteur Limited
Treatment for: Tetanus Prophylaxis, Diphtheria Prophylaxis, Pertussis Prophylaxis

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)) FDA Approval History

June 15

Tygacil (tigecycline) Injection

Date of Approval: June 15, 2005
Company: Wyeth Pharmaceuticals
Treatment for: Skin and Structure Infection, Intraabdominal Infection, Pneumonia

Tygacil (tigecycline) is a glycylcycline antibacterial indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia in adults.

Tygacil (tigecycline) FDA Approval History

June 16

Levemir (insulin detemir ) Injection

Date of Approval: June 16, 2005
Company: Novo Nordisk Inc.
Treatment for: Diabetes Type 1, Diabetes Type 2

Levemir (insulin detemir) is a novel, long- acting form of insulin that provides up to a 24-hour duration of action for the treatment of diabetes mellitus (type 1 and type 2).

Levemir (insulin detemir ) FDA Approval History

June 22

Aptivus (tipranavir) Capsules

Date of Approval: June 22, 2005
Company: Boehringer Ingelheim
Treatment for: HIV Infection

Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.

Aptivus (tipranavir) FDA Approval History

June 23

Synera (lidocaine and tetracaine) Topical Patch - formerly S-Caine Patch

Date of Approval: June 23, 2005
Company: ZARS, Inc.
Treatment for: Local Anesthesia

Synera (lidocaine and tetracaine) is a local anesthetic patch indicated for use on intact skin to provide local dermal analgesia before certain medical procedures

Synera (lidocaine and tetracaine) FDA Approval History

June 23

BiDil (isosorbide dinitrate and hydralazine) Tablets

Date of Approval: June 23, 2005
Company: NitroMed, Inc.
Treatment for: Congestive Heart Failure

BiDil is a fixed-dose combination of isosorbide dinitrate (a vasodilator) and hydralazine hydrochloride (an arterial dilator) indicated for the treatment of heart failure in black patients.

BiDil (isosorbide dinitrate and hydralazine) FDA Approval History

June 22

Aptivus (tipranavir) Capsules

Date of Approval: June 22, 2005
Company: Boehringer Ingelheim
Treatment for: HIV Infection

Aptivus (tipranavir) is a non-peptidic protease inhibitor which is co-administered with ritonavir for the treatment of HIV Infection.

Aptivus (tipranavir) FDA Approval History

January 2

Glumetza (metformin extended release)

New Dosage Form Approved: December 4, 2007

Glumetza (metformin extended release) FDA Approval History

June 24

Aptivus (tipranavir)

New Dosage Form Approved: June 23, 2008

Aptivus (tipranavir) FDA Approval History

March 24

Tygacil (tigecycline)

New Indication Approved: March 20, 2009

Tygacil (tigecycline) FDA Approval History

November 20

Revatio (sildenafil citrate)

New Dosage Form Approved: November 18, 2009

Revatio (sildenafil citrate) FDA Approval History

April 2

Levemir (insulin detemir )

Labeling Revision Approved: March 29, 2012

Levemir (insulin detemir ) FDA Approval History

May 22

Levemir (insulin detemir )

Patient Population Altered: May 18, 2012

Levemir (insulin detemir ) FDA Approval History

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