FDA Updates

Old Man Winter is back again, and consumers will be combing the aisles for cough, cold, and flu relief. What new remedies can be found on pharmacy shelves?

To help Type 2 diabetes patients better manage their blood glucose levels, Takeda Pharmaceuticals, Lincolnshire, Ill., (847) 383-3000, now has a new product that combines two diabetes medications in a single tablet.

With all of the hoopla in the lay press surrounding the Food & Drug Administration's refusal to approve Barr Pharmaceuticals' application for over-the-counter status of its emergency contraceptive (EC) Plan B (levonorgestrel), Barr held a press briefing in New York City to deliver a message.

San-Diego-based PrimaPharm Inc., (858) 259-0107, has gained approval for Hydase (hyaluronidase injection) as an adjuvant to increase the absorption and dispersion of other drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase was not available in the United States for several years. It was most commonly used in combination with local anesthetics in ophthalmic surgery.

When it comes to introducing new products in the oral care category, there seems to be no letup in sight.

Minneapolis-based Upsher-Smith Laboratories, (800) 654-2299, is introducing Vandazole (metronidazole vaginal gel, 0.75%) for the treatment of bacterial vaginosis in nonpregnant patients. According to the company, Vandazole offers an economical alternative to other available metronidazole treatments. It will be manufactured for Upsher-Smith by Teva Pharmaceuticals. The product is available in a 70-gm tube with five applicators.

Hoping to ward off what may be a significant cut in 2006 Medicare inhalation therapy dispensing fees, homecare pharmacists are aggressively disputing a recent report from the Office of Inspector General that concluded they are overpaid. They are lobbying Congress and the Centers for Medicare & Medicaid Services to avoid what industry officials fear may be a draconian reduction.

McNeil Consumer & Specialty Pharmaceuticals has launched an on-line educational campaign to inform patients of the importance of the proper use and storage of medications and of maintaining a healthy medicine cabinet. The campaign comes on the heels of a recent survey conducted for McNeil by Harris Interactive. The survey found that nearly half (46%) of American adults have taken an expired over-the-counter (OTC) medication.

Exclusive Drug Topics survey finds that most patients heed their R.Ph.'s OTC recommendations

Autumn is here and that means Old Man Winter and the cough and cold season are lurking around the corner.

The FDA has given marketing approval to Torontobased Biovail Corp., (905) 286-3000, for the company's once-daily Tramadol ER, an extended-release, oncedaily formulation of tramadol hydrochloride, in strengths of 100, 200, and 300 mg. The pain-killing medication is indicated for the treatment of moderate to moderately severe chronic pain in adults who require round-the-clock pain treatment.

A new flu vaccine, Fluarix (influenza virus vaccine), has received FDA approval and will be available for the upcoming 2005-06 flu season. Fluarix is indicated for adults age 18 and older and will be available in prefilled Tip-Lok syringes.

CMS is pursuing changes in the durable medical equipment (DME) benefit under the Medicare Modernization Act (MMA) that will have a profound effect on the way beneficiaries receive services and the way pharmacies and other DME suppliers provide those services. Laurence Wilson, director of the Chronic Care Policy Group for CMS' Center for Medicare Management, delivered this message to attendees of the National Association of Chain Drugstores Pharmacy and Technology Conference held recently in San Diego.

Exactacain is a new topical anesthetic from Collegium Pharmaceutical, Cumberland, R.I., (401) 762-2000. It will be marketed by Healthpoint Ltd. Exactacain (benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) spray controls the pain and suppresses the gag reflex in surgical, endoscopic, and other procedures. With the use of a disposable, single-use applicator, the three metered-dose sprays deliver rapid and steady anesthesia.

Many women experience vaginal dryness during menopause, following childbirth, during nursing, before menstruation, or when using tampons. It may also occur as a side effect from certain medications, as well as from stress and excessive exercise.

Can pharmacists play a major role in helping patients to kick butts? ASHP and the Joint Commission on Accreditation of Healthcare Organizations aren't taking No for an answer.

Taro Pharmaceuticals, Hawthorne, N.Y., (800) 544-1449, is introducing Lustra-Ultra (hydroquinone USP 4%), a third product in its Lustra line.

Once again it's back to school for millions of children nationwide. With this yearly event comes the inevitable arrival of pediculosis capitis—head lice—the bane of children who congregate in close quarters. Three million new cases are reported annually in the United States. Resistance is a growing concern as lice simply ignore conventional pediculicides. As experts note that resistance is much less likely to develop to therapies that do not work on a chemical level, a new wave of therapies use natural and non-neurotoxic treatments.

QLT USA Inc., Fort Collins, Colo., has FDA approval to market Aczone (dapsone) Gel 5%. The aqueous gel offers patients a topical treatment for acne vulgaris.

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

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.