FDA Updates

The Food & Drug Administration advisory panel's recent recommendation against OTC status for Merck's cholesterol drug Mevacor (lovastatin) has drawn renewed support and calls from pharmacists and pharmacy trade associations for the creation of a third class of drugs. A third class of drugs would allow patients to buy a drug without a prescription, but only after speaking with a pharmacist. In May 2004, Britain began selling the statin Zocor under these rules.

Extraneal (icodextrin 7.5%) Peritoneal Dialysis Solution has been approved for Baxter Healthcare Corp., Deerfield, Ill., (847) 948-2000. It is indicated for a single daily exchange for the long dwell during continuous ambulatory peritoneal dialysis or automated peritoneal dialysis for the management of end-stage renal disease. It is also indicated to improve long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined by the peritoneal equilibration test.

Many consumers can look to aches and pains from shoveling snow and exercising muscles that haven't seen a gym in years. And when they run to their pharmacy for relief from these complaints, they'll find a large selection of new over-the-counter pain patches, wraps, and sleeves.

Reliant Pharmaceutical, Liberty Corner, N.J., (908) 580-1200, has gained approval for a new lipid-lowering agent. Antara (fenofibrate) Capsules are indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides, and ApoB and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).

Reliant Pharmaceutical, Liberty Corner, N.J., (908) 580-1200, has gained approval for a new lipid-lowering agent. Antara (fenofibrate) Capsules are indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, triglycerides, and ApoB and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb).

Omacor, (omega-3 acid ethyl esters) will be marketed in the United States by Reliant Pharmaceuticals, Liberty Corner, N.J., (908) 580-1200.

Winter weather and seasonal ailments can take a toll on delicate lips. Every year, consumers rush to their pharmacies in search of relief from cold sores and chapped lips, and if the following new products are any indication, there will be much to choose from this time around.

Picture this scenario: You walk into a pharmacy and find a new category of nonprescription medications near the pharmacy. These "Pharmacy Care OTCs" are available only in an outlet with a pharmacy, and are intended to treat chronic and asymptomatic conditions as well as other conditions that lend themselves to counseling by a pharmacist.

Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has been granted a new indication for Femara (letrozole tablets).

This hasn't been a banner year for the Food & Drug Administration as guardian of our health and safety, for a storm of controversy has been following the agency like the black cloud that hovered over the head of cartoon character Mr. Mxyzptlk.

Valera Pharmaceuticals, Cranbury, N.J., (888) 262-8855, has approval to market the Vantas implant, designed for the continuous 12-month administration of histrelin, a gonadotropin-releasing hormone analog similar to one normally released from the hypothalamus gland. The long-acting implant will be used to treat locally advanced and metastatic prostate cancer.

Given the shortage of the flu vaccine and the recommendation by the Centers for Disease Control & Prevention to limit the shot to high-risk groups, this cough, cold, and flu season may hit unprotected children and adults especially hard. What products are available to help ease uncomfortable flu symptoms?

Carimune, the sterile, highly purified human plasma-derived intravenous immunoglobulin preparation from ZLB Behring, King of Prussia, Pa., (610) 878-4000, now carries new labeling.

As if store shelves aren't already groaning with all manner of dental products, more new SKUs have joined the fray.

NEW GENERICS

Consumers aren't making the most of their relationship with their pharmacist.

Consumers aren't making the most of their relationship with their pharmacist.

NEW DRUGS

New products (Rx, OTC, HBC, HHC, and ETC.) for DRUG TOPICS, September 13, 2004

Stockchecker on antacids.

DEA proposes security requirements for manufacturers, distributors, importers and exporters of pseudoephedrine, ephedrine and PPA

APha and J&J Merck launch American Pharmacists Month in October

New products (Rx, OTC, HHC, HBC, ETC.) for the Aug. 23, 2004 issue of DRUG TOPICS.

Survey finds schools of pharmacy don't offer otc courses. Covington offers examples of nonprescription curriculum.

McKesson rolls out FrontEdge Merchandiser program to help independents increase sales.

New cough/cold/flu/sore throat remedies are ready for fall/winter 2004.

New products: Rx, OTC, etc., for DRUG TOPICS Aug. 9, '04

lice treatments as kids head back to school 2004

Adverse drug reactions worldwide have prompted the World Health Organization to release new guidelines

The FDA recently approved codeine/chlorpheniramine (Codeprex, Celltech Group) extended-release suspension (CIII) for the temporary relief of cough, as may occur with the common cold or inhaled irritants, and for the temporary relief of runny nose; sneezing; itching of the nose or throat; and itchy, watery eyes due to hay fever, other upper respiratory allergies, or allergic rhinitis. The product is expected to be available in retail pharmacies by the fourth quarter.