Breaking News

April 18, 2005

The FDA has approved ondansetron (Zofran, GlaxoSmithKline) injection for the prevention of postoperative nausea and vomiting (PONV) in children as young as one month of age and chemotherapy-induced nausea and vomiting (CINV) in children as young as six months.

Depo subQ provera OK'd to treat endometriosis Medroxyprogesterone (Depo-subQ provera 104, Pfizer) injectable suspension has been granted approval for the management of pain associated with endometriosis. The drug is the first new treatment option for endometriosis pain to receive approval in 15 years. Depo-subQ provera was previously approved for use as a contraceptive. It is expected to become widely available next month.

FDA issues health advisory on Rx NSAIDs ... Several changes pertaining to the marketing of Rx NSAIDs have been made by the FDA. Pfizer was asked to withdraw valdecoxib (Bextra) from the market because of its unfavorable risk-versus-benefit profile. The company has agreed to suspend U.S. sales and marketing of valdecoxib, pending further discussions with the agency, which has also asked Pfizer to include a boxed warning on the celecoxib (Celebrex) label. Pfizer has agreed to work with the agency on the warning's content. The FDA is asking the makers of all other Rx NSAIDs to revise their labels to include this warning about the potential for increased risk of cardiovascular events and gastrointestinal bleeding associated with NSAID use. Manufacturers of Rx NSAIDs will also be asked to include a Medication Guide to make patients aware of the potential for adverse events. The advisory can be found at: http://www.fda.gov/cder/drug/advisory/ COX2.htm.

New drug approved for hepatitis B Entecavir (Baraclude, Bristol-Myers Squibb) 0.5- and 1-mg tablets have been approved for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. The drug became available in the United States earlier this month.

Final rule issued on fluorocarbons in albuterol MDIs The FDA announced that albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants may no longer be produced, marketed, or sold in the United States after Dec. 31, 2008. In a final rule, published in the April 4 issue of the Federal Register, HHS said sufficient supplies of two approved, environmentally friendly albuterol inhalers will exist by that date to allow the phasing out of similar less environmentally friendly versions. CFC-containing albuterol MDIs, along with other CFC-based MDIs for asthma and COPD, were previously exempted from a general ban of CFC production and importation under an international agreement established through the Montreal Protocol on Substances that Deplete the Ozone Layer and the U.S. Clean Air Act. Additional information is available at: http://www.fda.gov/cder/mdi/default.htm.