FDA Updates

As the pharmacy community complies with the Drug Enforcement Administration's interim final rule on retail sales of pseudoephedrine-related products, pharmacy and retail associations are preparing to send their comments to the agency outlining their members' concerns.

Squeezed by low and slow reimbursement from Medicare Part D, independent pharmacists have certainly taken their lumps this past year. But they still managed to eke out some victories, according to leaders of the National Community Pharmacists Association, which held its annual meeting in Las Vegas last month.

Glumetza (metformin hydrochloride extended-release tablet) is now available from King Pharmaceuticals, Bristol, Tenn., (423) 989-2000, and Depomed Inc., Menlo Park, Calif., (650) 462-5900. It offers once-daily oral dosing for adults with Type 2 diabetes. The tablets, manufactured by King, utilize Depomed's AcuForm drug delivery technology to provide controlled and prolonged release of metformin. The drug is indicated for use alone or in combination with sulfonylurea or insulin as an adjunct to diet and exercise for improved glycemic control.

From pills to patches, from implants to Plan B going OTC, women have more contraceptives to choose from today than ever before.

According to the company, this is the first FDA-approved orally disintegrating tablet form of prednisolone. The drug is used primarily for acute exacerbations of asthma in children and is also indicated for the control of severe, persistent asthma and to reduce the inflammation associated with various medical conditions, including arthritis and cancer. The drug will be marketed by Atlanta-based Alliant Pharmaceuticals.

The Sanovi-Aventis Group, with U.S. headquarters in Bridgewater, N.J., (908) 243-6000, and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000, now have FDA approval for a new indication for Plavix (clopidogrel bisulfate). The antiplatelet agent can now be used with aspirin in patients with the most severe type of heart attack-acute ST-segment elevation myocardial infarction (STEMI) who are not going to have coronary artery repair, or angioplasty. It was previously approved for helping reduce the risk of death, recurrent heart attacks, or strokes in patients with unstable angina or less severe heart attacks.

It looks like pharmacies will have to make room for yet another slew of new over-the-counter items. Take a peek at these cutting-edge products

After 11 years in business on Main Street in Aspen, Colo., Rodney Diffendaffer, R.Ph., knows too well that the struggle between community pharmacists and the mail-order industry is heating up, with generics fueling the fire. "They get to sell three months of drugs at what comes close to my one-month price," he said. "I'm not allowed to sell a three-month supply. It's not a level playing field. Never has been."

New product newswire

Picture this: A patient with a chronic disease answers questions about his condition via a countertop appliance at home. The answers are sent to a center staffed by nurses and other health professionals who monitor the patient's symptoms, vital signs, and medication use. If a problem is brewing, the professional informs the patient, his or her family caregiver, doctor, and/or pharmacist.

Searching for over-the-counter items on pharmacy shelves is going to get even more challenging with the battery of dental, analgesic, and other products manufacturers have just introduced. Take a look at these new entries:

AstraZeneca, Wilmington, Del., (800) 842-9920, has received FDA approval for Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol. The new inhaler is indicated for long-term maintenance treatment of asthma in patients 12 years of age and older.

The exhibit floor at the ASHP summer meeting in Orlando was sizzling with the latest wares on display for hospital pharmacy in categories ranging from automation solutions to dispensing equipment, computer hardware and software, drug administration devices, packaging equipment, and pharmacy management services.

AstraZeneca, Wilmington, Del., (800) 842-9920, has received FDA approval for Symbicort (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol. The new inhaler is indicated for long-term maintenance treatment of asthma in patients 12 years of age and older.

In time for back to school, manufacturers have introduced many lice busters, from products that contain natural ingredients to mechanical combs to remove nits and eggs. Here's a preview of this season's lice exterminators

GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, has received approval for Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation aerosol).

Like an ever-changing emporium, drugstores are showcasing many new OTCs. Here's a peek at the new merchandise.

Armed with a plethora of OTC test kits, consumers are taking do-it-yourself screenings to new heights

Armed with a plethora of OTC test kits, consumers are taking do-it-yourself screenings to new heights

Two new medications have been FDA-approved for Endo Pharmaceuticals, Chadds Ford, Pa., (800) 462-3636. Opana (oxymorphone hydrochloride) Extended-Release Tablets, available in 5-, 10-, 20-, and 40-mg strengths, are indicated for the relief of moderate to severe pain in patients requiring continuous, round-the-clock opioid treatment for an extended period of time. Opana Tablets are used for the relief of moderate to severe acute pain where the use of an opioid is appropriate. The drug is available in strengths of 5 and 10 mg.

There is still a lot we don't know about why tobacco cessation treatment works and which approach works best, according to a 14-member consensus panel, which met under the auspices of the National Institutes of Health (NIH) recently. However, said the committee's draft statement, effective interventions "are available and could double or triple quit rates, but not enough smokers are being offered these interventions."

New Product Newswire

Home care providers should be prepared to make changes in the way they do business now that the Centers for Medicare & Medicaid Services has published a proposed regulation that would implement competitive bidding programs for certain covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The proposed rule appeared in the May 1 Federal Register.

A consensus panel convened by the National Institutes of Health (NIH) has come down hard on the lack of science behind the use of multivitamin and mineral supplements for chronic disease prevention. Experts from across the country said that except in a few circumstances, there is not enough evidence to advise the public to take or not take them.

A synthetic cannabinoid agonist has received approval for marketing in the United States for the treatment of nausea and vomiting associated with cancer chemotherapy.

Battling the effects of aging is getting easier-sort of-thanks to manufacturers who are launching antiaging products for women and men.

When it comes to teenagers and drug abuse, there's good news and bad news. The bad news comes from a recent Partnership for a Drug-Free America Attitude Tracking study of parents and teens. The study reveals that nearly 20%-or more than 4.5 million-of teens report that they have intentionally abused prescription pain medications. One in 10 teens has abused nonprescription cough medicines with the ingredient dextromethorphan (DXM). The good news is that parents and pharmacists can have a major impact on significantly reducing this abusive behavior.

New product newswire

It can be the best time of the year, but poison ivy, muscle aches,insect bites, and scrapes can dampen summertime fun. New productscan ensure that the season is painless, and here's a sampling:

Hot flashes, depression, insomnia, and vaginal dryness are the onlysymptoms of menopause, right? Wrong. For many women, dry eye, too,is related to the changing hormone levels of menopause.