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...

Paliperidone palmitate (Invega Sustenna – Ortho-McNeil Janssen) has been approved by the FDA as a once-monthly injection for acute and maintenance treatment of schizophrenia in adults. An extended-release oral formulation (Invega) has been available since 2006.1 Long-acting injections of antipsychotic drugs typically are used to treat patients who cannot adhere to an oral regimen.2,3 Paliperidone is the primary active metabolite of risperidone (Risperdal), which is also available as a long-acting (every 2 weeks) injection. It is unclear whether either risperidone or paliperidone is a better...

Veltin Gel (Stiefel), a fixed-dose combination of the antibiotic clindamycin phosphate 1.2% and the retinoid tretinoin 0.025%, has been approved by the FDA for topical treatment of acne vulgaris in patients ≥12 years old. Another product containing the same active ingredients (Ziana) has been on the market since 2006.