Breaking News

November 8, 2004

Labeling revised to show orlistat reduces Type 2 diabetes risk

FDA approves new indication for Femara Letrozole (Femara, Novartis) tablets are approved for the extended adjuvant treatment of postmenopausal women with early-stage breast cancer who have received adjuvant tamoxifen therapy for five years. The approval of this new indication makes letrozole the first therapy approved in the U.S. for the post-tamoxifen treatment of early-stage breast cancer. Letrozole was previously approved for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer, and for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Discount Rx card to pay for R.Ph. services

Pharmacy-centric Medicare cards save millions According to NACDS, pharmacy-centric prescription discount cards have saved Medicare beneficiaries more than $118 million. Savings included more than $93 million for seniors using the $600 annual credit and more than $25.8 million for those who paid for their Rx discount savings cards. Pharmacy-centric cards include the following: Pharmacy Care Alliance Card, Community Care Rx, myPharmaCare Card, Walgreens Health Initiatives Card, and Rx Savings Access Card.

New hyaluronidase agent gets FDA OK Amphastar Pharmaceuticals began shipping its injectable hyaluronidase product, Amphadase 150 IU/ml, on Nov. 2. Amphadase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. The ready-to-use solution will be available in 2-ml vials containing 1 ml of drug solution; there will be 25 vials in each carton.

Heat can alter asthma drug efficacy New study findings suggest that mail-order prescriptions exposed to excessive heat, such as temperatures found in mailboxes, may become significantly less effective for patients. Results presented at CHEST 2004, held recently in Seattle, indicate that formoterol (Foradil, Novartis) delivered less than half of its expected dosage and showed significant physical changes after being exposed to 150°F for four hours. CHEST 2004 was the 70th annual scientific assembly of the American College of Chest Physicians.

Oral solution for levofloxacin cleared by FDA The FDA has approved levofloxacin (Levaquin, Ortho-McNeil) Oral Solution 25 mg/ml for the treatment of infections currently approved for the tablet and I.V. formulations. The new formulation is effective against Staphylococcus aureus, Streptococcus pneumoniae (including multidrug- resistant strains), Haemophilus influenzae, H. parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

Specialty drug use rising in kids Nearly $1 out of every $10 spent on drugs for children is used for high-priced specialty medications, according to a data analysis by Medco Health Solutions. The number of children ages 19 and under taking specialty drugs to treat rheumatoid arthritis has surged by 133%, and spending has risen 160% in the past two years. The rate of increased spending for RA specialty drugs has surpassed that of human growth hormone.

Petition filed on nuclear R.Ph. training