FDA actions in brief, August 2008

Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.

Methylphenidate extended-release tablets (Concerta, Johnson & Johnson) were approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults aged 18 to 65 years.

Dutasteride (Avodart, GlaxoSmithKline) was approved for use in combination with tamsulosin for the treatment of symptomatic enlarged prostate.

A combination of repaglinide and metformin (PrandiMet, Sciele/Novo Nordisk) was approved for the treatment of type 2 diabetes.

Zoledronic acid (Reclast, Novartis) was approved for the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.

An extended-release formulation of ropinirole (Requip XL, GlaxoSmithKline) was approved for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD). Rabeprazole (Aciphex, Eisai) was approved for the short-term (≤8 wk) treatment of gastroesophageal reflux disease (GERD) in adolescents aged ≥12 years.

Tipranavir capsules and oral solution (Aptivus, Boehringer Ingelheim) were approved for combination antiretroviral treatment of HIV-infected patients (adults and children aged 2–18 y) who are treatment experienced and infected with HIV-1 strains resistant to >1 protease inhibitor.

Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (Kinrix, GlaxoSmithKline) was approved for immunization against diphtheria, tetanus, pertussis, and polio diseases.

Diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (Pentacel, Sanofi Pasteur) was approved for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b.

Difluprednate ophthalmic emulsion 0.05% (Durezol, Sirion) was approved for the treatment of postoperative ocular inflammation and pain.