FDA Updates

A product of Farmacon-IL LLC, Westport, Conn., (203) 222-8801,NeoProfen (ibuprofen lysine) Injection is indicated to close a"clinically significant" patent ductus arteriosus in prematureinfants weighing 500-1500 grams and who are no more than 32 weeksof gestational age, after fluid restriction, diuretics, andrespiratory support have proven ineffective.

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.

The FDA has approved OsmoPrep Tablets (sodium phosphate monobasicmonohydrate/sodium phosphate dibasic anhydrous) from SalixPharmaceuticals, Raleigh, N.C., (919) 862-1000. The product isindicated for bowel preparation for colonoscopy in adults age 18and older.

Pharmacy is a key player in skin care. From rosacea to common skin infections and psoriasis, pharmacists are playing a growing role in the successful treatment of dermatological problems.

Mission Pharmacal Co. is introducing prescription Citracal Prenatal+ DHA to its line of calcium citrate supplements and prenatalvitamins.

Vitamins that are personalized by patients' genetic makeup. Home tests to identify vaginal infections. Refreshers for underarms. If you think these are ideas for products way off in the future, you're wrong, since they're here already.

RX

Picture this. A respiratory therapist uses a spirometer to determine a patient's lung age. Then a pharmacist provides information about the different types of smoking cessation products and how to use them. The patient also receives free nicotine replacement patches.

New product newswire

Spring is almost here and that means consumers will be heading outdoors. What new products are available to protect their skin from harmful UVA/UVB rays? Here's a look at some of the hot entries:

Sucampo Pharmaceuticals, Bethesda, Md., (301) 961-3400, along withTakeda Pharmaceuticals, will market newly approved Amitiza(lubiprostone).

For Cipher Pharmaceuticals, Mississauga, Ont., (905) 602-5840,Lipofen (fenofibrate capsules) has been approved in strengths of50, 100, and 150 mg.

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?

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.