September FDA Pipeline

September 1, 2004

New combinations

New combinationsVytorin

Ezetimibe and simvastatin

MERCK/SCHERING-PLOUGH

Cost. The ezetimibe/simvastatin combination tablet will be priced at $2.34 per dose for all doses, according to the manufacturer.

New indicationsAldara

Imiquimod cream, 5%

3M PHARMACEUTICALS

IMMUNE RESPONSE MODIFIER APPROVED FOR SUPERFICIAL BASAL CELL CARCINOMA

Atazanavir (Reyataz, Bristol-Myers Squibb) was approved for use with low-dose ritonavir (Norvir, Abbott) in treatment-experienced HIV-infected patients.

FDA approved levofloxacin tablets/injection and levofloxacin in 5% dextrose injection (Levaquin, Johnson & Johnson) to treat multi-drug resistant strains of Streptococcus pneumoniae in community-acquired pneumonia (CAP).

FDA approved lansoprazole (Prevacid, TAP Pharmaceutical Products) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in adolescent patients aged 12 to 17 years. Also approved was a delayed-release, orally disintegrating tablet formulation of lansoprazole (Prevacid SoluTab, TAP Pharmaceutical Products), which can be administered via an oral syringe or nasogastric tube.

Intradermal botulinum toxin type A (Botox, Allergan) was approved for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

FDA approved additional efficacy labeling for quetiapine (Seroquel, AstraZeneca). The data demonstrated that after 12 weeks, approximately two-thirds of patients receiving quetiapine as monotherapy achieved remission. The new label includes safety and efficacy data for mania associated with bipolar disorder extending up to Week 12.