FDA update on brand drugs for October 8, 2008

[chantell.reagan]

FDA update on brand drugs for October 8, 2008:

Akten (lidocaine 3.5% ophthalmic gel)
Approval: for ocular surface anesthesia during ophthalmologic procedures
∙ Link to FDA Letter:

o FDA Letter

Rapaflo (silodosin)
Approval: for the treatment of the signs and symptoms of BPH
∙ Link to Watson Press Release:

o Watson press release, 10/08

Reyataz (atazanavir sulfate):
Expanded indications: for use in combination with ritonavir for the treatment of newly diagnosed HIV-1 infection
∙ Link to FDA Letter:

o FDA Letter

∙ Link to Prescribing Information:

o Prescribing Information

Seroquel XR (quetiapine sulfate):
Expanded indications: for use as monotherapy in bipolar depression/mania and as adjunctive therapy in bipolar mania
New formulation: 50 mg tablet for initiation of dose titration at a lower starting dose (previously approved, but not marketed)
∙ Link to FDA Letter:

o FDA Letter

Zmax® (azithromycin extended release) for oral suspension:
Expanded indications: for use in pediatric patients with community acquired pneumonia
∙ Link to FDA Letter:

o FDA Letter

Fluoroquinolone class: Cipro/Cipro XR/Proquin XR (ciprofloxacin), Factive (gemfloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin):
Safety update: Class black box warning: associated with increased risk of tendinitis and tendon rupture in all ages, with increased risk in patients over 60 years old, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants.

• Sample FDA Letter: FDA Letter

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA