FDA Updates

RxNEW DRUGS The FDA has approved Balacet 325 (100 mg propoxyphene napsylate/325 mg acetaminophen) tablets (CIV) for the treatment of mild to moderate pain in patients aged 18 years and older.

Yes, it's summer. The best time of the year. But it's also when consumers get aches, pains, cuts, scratches, and insect bites from participating in outdoor activities.

Changing market conditions are catapulting pharmacists into the pivotal role of patrolling a third class of drugs.

BioMarin Pharmaceutical, Novato, Calif., (415) 884-6700, has gainedFDA approval for Naglazyme (galsulfase), the first specifictreatment for mucopolysaccharidosis VI (MPS VI), suffered byapproximately 1,100 persons in the developed world. Granted orphandrug status in the United States, Naglazyme will have seven yearsof market exclusivity. MPS VI is a serious and debilitatingdisease, and most of those afflicted die from its complicationsbetween childhood and early adulthood.

A dizzying array of new products was highlighted at the National Association of Chain Drug Stores Marketplace 2005 conference, held in New Orleans last month. At this largest front-end trade show in the industry, the buzzword was natural, with the majority of new products containing natural ingredients to satisfy customer demand for safer solutions to healthcare problems. Here's a look at the new entries in personal care, dietary supplementation, and home health care.

The sun is not the only thing heating up this summer. Controversy is sizzling over whether it is safe for people to get vitamin D from exposure to sunlight and whether sunscreen ingredients can cause cancer. There have been reports claiming that some people aren't getting enough vitamin D because they avoid sun exposure and use sunscreens regularly. In addition, reports in the lay press and medical journals suggest that sunscreens may cause cancer.

Attendees at the National Association of Chain Drug Stores Marketplace 2005 Conference in New Orleans got an idea of what lies ahead regarding the regulation of pseudoephedrine-containing products.

Approved for the treatment of uncomplicated urinary tract infections, Proquin XR is claimed to be an "improved version" of ciprofloxacin. The quinolone antibiotic offers a slow and steady release of the drug over the course of six hours, avoiding the release of a large quantity of the agent over a shorter period of time and causing fewer incidences of nausea and diarrhea. The maker is Depomed Inc., Menlo Park, Calif., (650) 462-5900.

Picture this scenario: A state employee health plan switches patients from an Rx to an over-the-counter (OTC) drug. Pharmacists help expedite the switch without taking a hit to their pharmacy's bottom line. An unimaginable concept, right?

From GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, comes Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap]). The product is indicated as a booster vaccine to be given as a single dose to patients aged 10 to 18. This booster adds a pertussis component to the tetanus/diphtheria booster routinely administered to teens.

From GlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, comes Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed [Tdap]). The product is indicated as a booster vaccine to be given as a single dose to patients aged 10 to 18. This booster adds a pertussis component to the tetanus/diphtheria booster routinely administered to teens.

When the cough and cold season arrives this fall, consumers will be bombarded with a barrage of new over-the-counter medicines that contain the ingredient phenylephrine (PE).

Having been granted both orphan and fast-track designation by the FDA, Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg was approved for Bausch & Lomb, Rochester, N.Y., (800) 344-8815. The drug, indicated for treating chronic noninfectious uveitis affecting the posterior segment of the eye, comes as a small pellet that is surgically inserted into the eye.

Just as pharmacists begin to think that their shelves are packed as tightly as possible with oral care products, here comes yet another wave of new items to stock up on. Consider the following new entries

Now available from Watson Pharmaceuticals, Corona, Calif., are one-month and three-month sustained-release formulations, respectively, of a drug approved earlier.

Spring has sprung and that means for the next few months consumers will be perusing the aisles in search of remedies for an assortment of annoying warm weather maladies, including poison ivy, allergies, insect bites, and overexertion.

The National Home Infusion Association (NHIA) held an audio conference recently to alert home infusion providers to the challenges they may face when the new Medicare Part D prescription drug benefit is implemented on Jan. 1, 2006.

Top 200 OTC/HBC brands in 2004

Pan American Laboratories (PAMLAB, LLC), Mandeville, La., (985) 893-4097, is introducing Metanx tablets, a prescription-only medical food for the dietary management of patients who are under a physician's care for endothelial dysfunction and hyperhomocysteinemia. Each tablet contains 2.8 mg of L-methylfolate, as well as active forms of pyridoxine (vitamin B6) and cobalamin (vitamin B2). Metanx tablets contain no sugar, lactose, yeast, or gluten. The customary dosage is one or two tablets daily.

How do dietary supplements affect patients who are on blood-thinning medications and antithrombotic therapies? The National Institutes of Health held a two-day conference on this subject in Bethesda, Md., recently.

Marlborough, Mass.-based Sepracor Inc., (877) SEPRACOR, has received FDA approval for Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, for the treatment or prevention of bronchospasm in adults, adolescents, and children four years of age and older with reversible obstructive airway disease.

The Hamacher Resource Group provided the information for this article. The Milwaukee company provides marketing services and business intelligence to the healthcare industry. Wholesalers, manufacturers, and retailers partner with Hamacher Resource Group to improve their profitability. For more information, visit www.hamacher.com.

Hyperammonemia, a condition of dangerously heightened levels of ammonia in the bloodstream, can be life-threatening in patients with urea cycle disorder (UCD), an inborn error of urea cycle metabolism. Ammunol, from Medicis Pharmaceutical Corp., Scottsdale, Ariz., (602) 808-8800, combines 10% sodium phenylacetate and 10% sodium benzoate in a new product intended for intravenous hospital use in the event of hyperammonemic crisis. The drug was recently approved for marketing as a "rescue medication."

The FDA has approved Nascobal (cyanocobalamin USP) Nasal Spray for Nastech Pharmaceutical, Bothell, Wash., (888) 514-5208. The intranasal spray is indicated for vitamin ?2 deficiency in patients with pernicious anemia, Crohn's disease, HIV/AIDS, and multiple sclerosis.

Oklahoma pharmacists will soon have a central database to check in real time whether consumers seeking to purchase pseudoephedrine tablets have exceeded the state's monthly quota of 9 gm per person.

The days are getting longer, and consumers will be spending more daylight hours outdoors. What new products are available to protect their skin from the sun's harmful rays?

There is good news for patients with non-Hodgkin's lymphoma. An expanded indication for Bexxar Therapeutic Regimen (tositumomab and Iodine I131 tositumomab), from GlaxoSmithKline, Philadelphia, (888) 825-5249, will allow patients to reap the potential benefits of the medication earlier in their course of treatment. Bexxar Therapeutic Regimen can now be used for the treatment of patients with CD 20 antigenexpressing relapsed or refractory low-grade, follicular, or transformed non-Hodgkin's lymphoma, whose disease has relapsed following chemotherapy. The original indication covered patients with disease that was refractory to rituximab and who had relapsed following chemotherapy. The regimen, intended as a single course of treatment, is not indicated for the initial treatment of patients with CD 20-positive non-Hodgkin's lymphoma.

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.

We spend too much on curative care and not enough on preventive care. Treating disease is one thing; preventing it is even better."