New Drug Approvals Archive

New Drug Approvals: June 2005

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 Aventis Pasteur Limited - Treatment for Prevention of Tetanus, Diphtheria & Pertussis
 
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 Wyeth Pharmaceuticals - Treatment for Complicated Skin and Intra-abdominal Infections
 
June 16
Levemir (insulin detemir ) Injection

Date of Approval: June 16, 2005

Company: Novo Nordisk Inc.

Treatment for: Diabetes Mellitus Type I, Diabetes Mellitus Type II

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 Novo Nordisk Inc. - Treatment for Diabetes Mellitus (Type 1 and Type 2)
 
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.

FDA Approves Aptivus for HIV Infection
 
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 NitroMed, Inc. - Treatment for Heart Failure in Black Patients
 
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) Capsules Granted Full Approval by the U.S. FDA
 
June 24
Aptivus (tipranavir)

New Dosage Form Approved: June 23, 2008

New Aptivus (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients
 
March 24
Tygacil (tigecycline)

New Indication Approved: March 20, 2009

FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
 

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