FDA Updates

Armed with a plethora of OTC test kits, consumers are taking do-it-yourself screenings to new heights

Two new medications have been FDA-approved for Endo Pharmaceuticals, Chadds Ford, Pa., (800) 462-3636. Opana (oxymorphone hydrochloride) Extended-Release Tablets, available in 5-, 10-, 20-, and 40-mg strengths, are indicated for the relief of moderate to severe pain in patients requiring continuous, round-the-clock opioid treatment for an extended period of time. Opana Tablets are used for the relief of moderate to severe acute pain where the use of an opioid is appropriate. The drug is available in strengths of 5 and 10 mg.

There is still a lot we don't know about why tobacco cessation treatment works and which approach works best, according to a 14-member consensus panel, which met under the auspices of the National Institutes of Health (NIH) recently. However, said the committee's draft statement, effective interventions "are available and could double or triple quit rates, but not enough smokers are being offered these interventions."

New Product Newswire

Home care providers should be prepared to make changes in the way they do business now that the Centers for Medicare & Medicaid Services has published a proposed regulation that would implement competitive bidding programs for certain covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The proposed rule appeared in the May 1 Federal Register.

A consensus panel convened by the National Institutes of Health (NIH) has come down hard on the lack of science behind the use of multivitamin and mineral supplements for chronic disease prevention. Experts from across the country said that except in a few circumstances, there is not enough evidence to advise the public to take or not take them.

A synthetic cannabinoid agonist has received approval for marketing in the United States for the treatment of nausea and vomiting associated with cancer chemotherapy.

Battling the effects of aging is getting easier-sort of-thanks to manufacturers who are launching antiaging products for women and men.

When it comes to teenagers and drug abuse, there's good news and bad news. The bad news comes from a recent Partnership for a Drug-Free America Attitude Tracking study of parents and teens. The study reveals that nearly 20%-or more than 4.5 million-of teens report that they have intentionally abused prescription pain medications. One in 10 teens has abused nonprescription cough medicines with the ingredient dextromethorphan (DXM). The good news is that parents and pharmacists can have a major impact on significantly reducing this abusive behavior.

It can be the best time of the year, but poison ivy, muscle aches,insect bites, and scrapes can dampen summertime fun. New productscan ensure that the season is painless, and here's a sampling:

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.

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.

Keeping up with new health and beauty care (HBC) product introductions is no easy task, let alone evaluating each item for its profit potential and orientation for the drugstore class of trade. Studying the store's product assortment is not always a realistic goal for busy pharmacists and pharmacy managers.

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?