Jane S. Ricciuti, RPh, MS


March 19, 2003

In This Article

Antineoplastic Agents

(letrozole) Tablets

Manufacturer: Novartis

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 01/17/03)

Clinical Summary: The package labeling of Femara (letrozole) has been revised to include new safety and efficacy data regarding the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. The new labeling contains data following patients to 32 months; previously, the package labeling contained data on patients who were followed for 18 months. Table 1 and Table 2 summarize the changes in data contained in the Femara product labeling.

Precautions: The following statement was added to the "Precautions" section of the Femara labeling:

  • Since fatigue and dizziness have been observed with the use of Femara and somnolence was uncommonly reported, caution is advised when driving or using machinery.

Femara (letrozole) Tablets Labeling

Femara (letrozole) Tablets


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