FDA Updates

New Rx New Generics

What follows is a review of the biggest news of 2006 in just a few categories, along with their new product standouts.

The FDA recommends that you counsel patients on the importance of reading product labels carefully to determine the active ingredients and dosing instructions of each product and to discourage them from making assumptions about use based on product names or appearance. The use of similar trade names (so-called "brand-name families") is common practice for OTC products. The products with the trade names "Sudafed" and "Sudafed PE" illustrate specific concerns.

A group of researchers at the University of Florida College of Pharmacy recently submitted a citizen's petition asking the Food & Drug Administration to increase the maximum allowable dose of phenylephrine (PE) from 10 mg to 25 mg and to withdraw approval of phenylephrine for children under 12 years of age. The petition also called for additional research to validate the safety and effectiveness of the higher recommended dose.

The new guide recommends that physicians start with nonpharmacologic treatments such as exercise, physical therapy, weight loss, and heat or cold therapy. If there is no relief of pain, physicians should consider acetaminophen, aspirin, and even short-term use of narcotic analgesics as a first step, taking the patient's medical history into account.

New product Newswire

Mission Pharmacal, San Antonio, (210) 696-8400, is introducing a new prenatal vitamin. Citracal Prenatal 90 + DHA was formulated for women before, during, and after pregnancy. The product contains life'sDHA-a vegetarian form of DHA omega-3-along with prescription-strength vitamins and minerals.

Mission Pharmacal, San Antonio, (210) 696-8400, is introducing a new prenatal vitamin. Citracal Prenatal 90 + DHA was formulated for women before, during, and after pregnancy. The product contains life'sDHA-a vegetarian form of DHA omega-3-along with prescription-strength vitamins and minerals.

Pharmacists appear pleased with the Food & Drug Administration's recent decision to allow orlistat 60-mg capsules to go over the counter (OTC) in the United States. (See Latebreakers, Feb. 19.) The OTC version, to be marketed by GlaxoSmithKline beginning this summer under the brand name alli, is for use by overweight adults 18 years and older in conjunction with a reduced-calorie, low-fat diet.

A new specialty certification may be on the horizon. The Board of Pharmaceutical Specialties (BPS) could offer ambulatory care certification as early as 2008. "BPS got the ball rolling, but we have not committed to the development of this specialty," said BPS executive director Richard Bertin. "It is up to the profession to present arguments, pro and con, before that decision can be made."

Migraines are now viewed as a chronic disorder with episodic manifestations, and emphasis should be put on evaluating impairment between headache attacks. This is the gist of a new consensus statement recently released by the National Headache Foundation (NHF), an organization focusing on migraine prevention.

The basic principle of health-care treatment-"First, do no harm"-should apply also to the proper disposal of hazardous pharmaceutical waste. A new product, EcoRex, from Vestara in Irvine, Calif., is designed to achieve that end, using customized software to reduce the potential harm of such waste.

A new treatment is available for patients 12 years of age and older with psoriasis and eczema. Olux-E (clobetasol propionate) Foam, 0.05%, available in 50-and 100-gm canisters, is indicated for inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Traditional over-the-counter and health and beauty care items as we know them are going the way of the automat. Here's a look at some of the unique items that are taking their place

Picture this. A man walks into a pharmacy to buy condoms. He hopes he can quickly whisk them from the shelf and pay for them without attracting attention. But ... they are locked up in a case along with the razor blade cartridge replacements. A note on the cabinet states, "Please ask attendant for assistance for items in this case."

Cyanokit (hydroxocobalamin for injection), for intravenous infusion, has been FDA-approved for the treatment of known or suspected cyanide poisoning. The product is manufactured by EMD Pharmaceuticals, Durham, N.C., (919) 401-7100.

It is that time of the year when consumers flock to their local drugstores seeking the "long-trusted" remedies for the common cold and its associated symptoms-particularly cough. In response, pharmacists will be called upon to make therapy recommendations that suit the needs of each individual patient.

Congress just passed and President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), also known as the Adverse Event Reports (AER) bill. The legislation will amend the federal Food, Drug & Cosmetic Act to require manufacturers to report "serious" adverse events for OTC drugs and dietary supplements to the Food & Drug Administration. The law becomes effective one year after its passage on Dec. 26.

Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, has received tentative approval for a new treatment option for patients with high blood pressure, although not for initial therapy. Exforge (valsartan and amlodipine besylate) will provide combination therapy in a single tablet made up of Novartis' Diovan and Pfizer's Norvasc.

Retailers may want to make room for a variety of OTCs that feature unique formulations. Here's a preview of the over-the-counter items manufacturers are releasing:

Verdeso (desonide) Foam, 0.05%, has been FDA-approved for the treatment of mild to moderate atopic dermatitis (eczema) in adults and children as young as three months of age. The low-potency topical steroid is the product of Connetics Corp., Palo Alto, Calif., (650) 843-2800.

The Transportation Security Administration's recently revised ban on certain health and beauty care and over-the-counter items has baffled, frustrated, and inconvenienced many air travelers. But not Jodi Nass.

Manufacturers are busy churning out a slew of over-the-counter and health and beauty care items infused with flavors, botanicals, nutraceuticals, and other natural ingredients.

An expert panel convened by the Alzheimer?s Drug Discovery Foundation recently released consensus recommendations on the treatment of Alzheimer?s disease and related dementias (ADRD) in managed care. The guidelines were published as a supplement to the American Journal of Geriatric Pharmacotherapy.

New product newswire

An expert panel convened by the Alzheimer?s Drug Discovery Foundation recently released consensus recommendations on the treatment of Alzheimer?s disease and related dementias (ADRD) in managed care. The guidelines were published as a supplement to the American Journal of Geriatric Pharmacotherapy.

In time for the upcoming 2006-07 flu season, a new influenza immunization is available from GlaxoSmithKline. FluLaval (Influenza Virus Vaccine) has been approved for the active immunization of adults 18 years of age and older against influenza types A and B. FluLaval, already marketed in Canada under the name Fluviral, will be available in 10-dose multi-dose vials.

Manufacturers are churning out yet another barrage of OTCs. Here's a peek.

Cephalon Inc., Frazer, Pa., (610) 344-0200, has approval from the FDA to market Fentora (fentanyl buccal tablet) C-II. The opioid agonist, available in strengths of 100, 200, 400, 600, and 800 mcg, is indicated for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for underlying, persistent cancer pain. Cephalon's OraVescent drug delivery system allows much of the medication to be absorbed directly across the lining of the upper cheek and into the bloodstream.

Make room for yet another deluge of over-the-counter products. Here's a glimpse.