Ciclopirox nail lacquer (Penlac - Dermik) has been approved by the FDA for treatment of mild-to-moderate onychomycosis due to Trichophyton rubrum, without involvement of the lunula. The drug has been available for many years as a lotion and cream (Loprox) for treatment of cutaneous fungal infection

Photodynamic therapy with verteporfin (Visudyne--CIVA Vision), an injectable drug, is now being used for treatment of age-related macular degeneration. The drug is a benzoporphyrin derivative that, when activated by light in the presence of oxygen, generates highly reactive radicals that damage neovascular endorthelium and occlude the vessels.

Rivastigmine tartrate (Exelon - Novartis), a carbamate-based cholinesterase inhibitor, is now being marketed for treatment of patients with dementia due to Alzheimer's disease.

Zoledronic acid (Zometa), a new bisphosphonate, has been approved by the FDA for intravenous (IV) treatment of hypercalcemia of malignancy.

Recombinant human granulocyte colony stimulating factor (G-CSF, filgrastim) conjugated to polyethylene glycol (pegfilgrastim, Neulasta - Amgen) has been approved by the FDA for use in neutropenic patients with non-myeloid malignancies who are at high risk for infection. Filgrastim (Neupogen - Amgen) has been available in the US since 1991.

Dexmethylphenidate (Focalin - Novartis), a new formulation of methylphenidate (Ritalin, and others) is now available for treatment of attention deficit/hyperactivity disorder (ADHD). Dexmethylphenidate is the d-threo-enantiomer of racemic methylphenidate. "Now the right half may be all your patients need," said a recent ad. Focalin is the third new methylphenidate formulation marketed in the last two years.

Three beta interferons are widely used in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).

The FDA has approved the marketing of loratadine (Claritin - Schering), a second-generation H₁-antihistamine, without a prescription. The drug was also recently approved for OTC use as Alavert (Wyeth) and other generics are expected.

The fixed-dose combination of olanzapine and fluoxetine (Symbyax - Lilly) has been approved by the FDA for treatment of depressive episodes associated with bipolar disorder. Olanzapine alone (Zyprexa), which is mainly used as an antipsychotic (Medical Letter 2003; 45:102), is FDA-approved for treatment of acute manic episodes and for maintenance treatment of bipolar disorder. Fluoxetine alone (Prozac, and others), which is mainly used as an antidepressant (Medical Letter 2003; 45:93), has no specific approval for use in bipolar...

Medical Letter consultants have brought to our attention some confusion that has accompanied the release of Adacel, a combination of tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap) recently approved for use as a booster in adolescents and adults 11-64 years old (Med Lett Drugs Ther 2006; 48:5). Another Tdap vaccine, Boostrix, is approved for use in adolescents 10-18 years old. Some adults have inadvertently been immunized with Daptacel or Infanrix (DTaP), which are intended for active immunization of infants and children 6 weeks to 6 years old. Such mix-ups were...