Latebreakers: July 24, 2006

NABP service verifies on-line pharmacy licensure

CDC's HPV vaccine recommendations

Zoloft patent expiration sparks battle royal

Close on the heels of Zocor (simvastatin, Merck) going off patent (see page 10), another heavy hitter, Zoloft (sertraline, Pfizer), is going generic. The FDA has approved Teva's 25-, 50-, and 100-mg tablet form of the antidepressant and Roxane's 20 mg/ml liquid version. They will be competing with Pfizer's own deeply discounted copycat version. The genericization of Zoloft is expected to produce significant savings for consumers. The Regence Group, which includes healthcare plans in four states in the Northwest, alone expects to save more than $60 million annually.

Expanded use for Revlimid approved

Lenalidomide (Revlimid, Celgene) has been granted approval for an additional indication. The drug can now be used in combination with dexamethasone as a treatment for multiple myeloma in patients who have received at least one prior therapy. Lenalidomide was previously approved for the treatment of transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Because of its potential to cause birth defects, lenalidomide is available only through a restricted distribution program called RevAssist.

Accelerated approval for CML therapy

Bristol-Myers Squibb has received accelerated approval for its tyrosine kinase inhibitor dasatinib (Sprycel) for the treatment of adults with all phases of chronic myeloid leukemia (CML), an approval that will be converted to a full approval following submission of follow-up data from ongoing studies to the FDA. Clinical studies in more than 400 patients showed that, for patients with the chronic phase of CML, treatment with the new drug resulted in a response in 45% of patients. Response rates in patients with advanced phases of the disease ranged from 31% to 59%, lasting at least six months in most patients. The drug simultaneously received a full approval from the agency for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Dasatinib is considered an orphan drug for each indication.

New safety warnings for HIV drug

Boehringer Ingelheim has issued a Dear Healthcare Professional letter after identifying 14 cases of intracranial hemorrhage (ICH) events, including eight fatalities, in 13 out of 6,840 HIV patients taking tipranavir (Aptivus) in combination with ritonavir (Norvir, Abbott). The manufacturer has revised the product's prescribing information to reflect the new findings and warns that the tipranavir should be used with caution in patients who may be at risk for increased bleeding from trauma, surgery, or other medical conditions, including patients taking antiplatelet agents or anticoagulants.