FDA Updates

The FDA gave marketing approval to ZLB Behring, King of Prussia,Pa., for an immunoglobulin (Ig) replacement therapy that can beself-administered by patients at home. Vivaglobin (immune globulinsubcutaneous [human]), indicated for treating patients with primaryimmunodeficiency, delivers antibodies subcutaneously, as analternative to intravenous infusions of immunoglobulin, to fightlife-threatening infections. The firm can be reached at (610)878-4000.

The FDA gave marketing approval to ZLB Behring, King of Prussia,Pa., for an immunoglobulin (Ig) replacement therapy that can beself-administered by patients at home. Vivaglobin (immune globulinsubcutaneous [human]), indicated for treating patients with primaryimmunodeficiency, delivers antibodies subcutaneously, as analternative to intravenous infusions of immunoglobulin, to fightlife-threatening infections. The firm can be reached at (610)878-4000.

Consumers who are sticking to their New Year's resolution to get in shape may be looking for products to ease the aches and pains that come with working out. What new OTCs will these exercise buffs find on pharmacy shelves to treat their discomfort?

On Jan. 23, the Food & Drug Administration's Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee began a review of GlaxoSmithKline's application proposing OTC use of 60-mg orlistat (Xenical) capsules to promote weight loss in overweight adults when used along with a reduced-calorie and low-fat diet. The agency is expected to make a decision by March. The drug's proposed name is Alli.

Biovail Corp., Toronto, (905) 286-3000, has received an approvalletter from the FDA for its orally disintegrating tabletformulation of citalopram hydrobromide for the treatment ofdepression. Citalopram ODT, a tablet version of immediate-releasecitalopram HBr, a selective serotonin reuptake inhibitor, isavailable in 10-, 20-, and 40-mg strengths. It offers a choice ofdosage form for patients with difficulty swallowing or those havingno access to water.

The cold, dry winter air can wreak havoc on consumers' skin, causing chapped lips and cracked feet. Manufacturers have unleashed a slew of new products to treat these conditions. Here's a sampling of products coming soon to pharmacy shelves

Like a Turkish bazaar, the exhibit floor of the recent ASHP midyear conference, drawing an eye-popping attendance of 20,000 registrants, showcased many new products for health-system pharmacists. Here are some of the new wares displayed at the Las Vegas show

Avandaryl Tablets (rosiglitazone maleate and glimepiride), fromGlaxoSmithKline, Research Triangle Park, N.C., (919) 483-2100, havereceived FDA approval. The drug is indicated as an adjunct to dietand exercise to improve glycemic control in Type 2 diabetespatients already treated with a combination of rosiglitazone andsulfonylurea, for patients not adequately controlled on asulfonylurea alone, or for patients who have responded initially torosiglitazone alone but require additional glycemic control.

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?

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

Carrying the first new therapeutic mechanism of action in 35 years, according to manufacturer Takeda Pharmaceuticals, Rozerem (ramelteon) 8-mg tablets are now available for the treatment of insomnia characterized by difficulty with sleep onset.

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.