FDA Updates

Subzero temperatures and dry, indoor air can wreakssss havoc on skin over a long winter. Consumers who develop tiny cracks on their fingers and feet will find new ointments and creams specifically formulated to provide relief from these painful sores. Here"s a sampling of some promising new items consumers will find on drugstore shelves:

Joe Graedon, pharmacologist, author, and syndicated health talk show host of "People's Pharmacy," is enthusiastic about future growth opportunities for pharmacists. He was very disappointed with the recent Food & Drug Administration decision denying Merck permission to market its statin drug Mevacor (lovastatin) over the counter.

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.

NEW PRODUCT NEWSWIRE

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.

New Product Newswire

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).

New Product Newswire

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).

New Product Newswire

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.

New Product Newswire

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

NEW PRODUCT NEWSWIRE

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?

New Product Newswire

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.

New Product Newswire

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

New Product Newswire

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