Latebreakers

September 26, 2005

The indications for Novo Nordisk's NovoLog (insulin aspart [rDNA origin]) injection have been expanded to include the treatment of diabetes in children. NovoLog was found to be safe and effective in patients aged two to 18 years who have diabetes. The rapid-acting insulin analog was approved in 2000 for use in adults.

NovoLog now approved to treat children

Remicade adds UC to list of indications

FDA proposes rule on CGMP for PET drugs

The FDA has released a proposed regulation for the current good manufacturing practices (CGMP) for the production of positron emission tomography (PET) drugs. PET drugs are used as part of a medical diagnostic tool to help diagnose diseases such as cancer and heart disease. The regulation, which establishes minimum standards for the production and testing of PET drug products, is intended to ensure that PET drugs meet the requirements of the FD&C act as to safety, identity, strength, quality, and purity. The FDA is providing a 90-day public comment period on the proposed regulation and the draft guidance, which describes acceptable approaches that would enable PET drug producers to meet the requirements outlined in the proposed regulation. For more information, go to http://www.fda.gov/cder/regulatory/pet/default.htm.

All Vioxx returns must be in by Sept. 30

Merck & Co., which last year announced the immediate and voluntary withdrawal of Vioxx (rofecoxib), has informed pharmacists that in order to be eligible for reimbursement of returned Vioxx, all returns must be submitted no later than Sept. 30. Product returned with postmarks after that date will be accepted for destruction only. No reimbursement will be provided for any returns sent with a postmark dated after Sept. 30. All returns should be directed to NNC Group, Attn: Merck Returns, 2670 Executive Drive, Indianapolis, IN 46241. For questions, contact NNC at 1-(800) 805-9542. For product and service information, contact 1-(800) NSC-Merck.

Hurricane buys pharmacy some more time

Hurricane Katrina has given pharmacists a reprieve of sorts. Congress was initially set to cut $10 billion in Medicaid spending over the next five years as part of its Medicaid budget legislation due by Sept. 16. Now legislators have set their deadline back by two weeks in order to focus immediately on relieving Katrina victims. NACDS hopes Congress won't be able to go forward with its plans for Medicaid cutbacks when so many people have been displaced by the hurricane. (See earlier story)