New Product Newswire

NEW PRODUCT NEWSWIRE

NEW FORMULATIONS

Reminyl (galantamine hydrobromide), a new treatment for mild to moderate Alzheimer's disease from Janssen Pharmaceu-tica, has received FDA approval for a 4mg/ml oral solution. Previously available in tablet form only, Reminyl's oral solution is appropriate for patients who cannot swallow tablets or who prefer to drink a liquid. Clinical studies have shown that Reminyl can have a beneficial effect on patients' daily function and ability to think. The recommended starting dose of 8 mg should be divided into two doses, preferably given with the morning and evening meals. Janssen Pharmaceutica, based in Titusville, N.J., can be reached at (609) 730-2000. For the full prescribing information, go towww.reminyl.com.

Collagenex Pharmaceuticals, Newtown, Pa., (888) 339-5678, has introduced a tablet formulation of Periostat (doxycycline hyclate) to replace the current capsule formulation and offer a smaller "patient-friendly" pill that may be easier to swallow. Periostat 20 mg (one tablet taken twice daily), indicated as an adjunct to a deep-cleaning dental procedure known as scaling and root planing, has been shown in clinical studies to significantly improve the health and stability of teeth and gums.

NEW GENERICS

Bedford Laboratories has rolled out two new products. Haloperidol injection USP, a generic equivalent to Ortho-McNeil's Haldol, is an antipsychotic indicated for the management of psychotic disorders. The generic injection is available in 1-ml vials and 10-ml multiple-dose vials, equivalent to 5 mg/ ml haloperidol. The Bedford, Ohio, firm has also started marketing thiotepa for injection USP. Equivalent to Immunex Corp.'s Thioplex, the drug is indicated as a palliative for many neoplastic diseases. Bedford's 15-mg single-dose vial unit carton has a 12-month expiration, while Immunex's product has a nine-month expiration. Bedford can be reached at (440) 232-3320.

Lovastatin is now available generically in 10-mg, 20-mg, and 40-mg tablets from Eon Labs, Mylan Laboratories, and TEVA Pharmaceuticals. The agent offers a generic alternative to Merck's cholesterol-lowering drug Mevacor. Eon, Laurelton, N.Y., can be reached at (800) 526-0225. Mylan is in Pittsburgh, at (800) RXMYLAN. TEVA is in North Wales, Pa., at (888) TEVA USA.

IMPAX Laboratories' terbutaline sulfate tablets (2.5 mg and 5 mg), a generic version of Brethine by Novartis, has received FDA approval. The tablets are indicated for the prevention and reversal of bronchospasm. IMPAX, based in Hayward, Calif., can be reached at (510) 471-3600.

Mylan Laboratories has received FDA approval to manufacture buspirone hydrochloride tablets 30 mg. As the generic equivalent of BuSpar tablets, from Bristol-Myers Squibb, buspirone HCl is indicated for the management of anxiety disorders or the short-term relief of anxiety. Based in Pittsburgh, Mylan can be contacted at (412) 232-0100.

Pharmaceutical Resources Inc. (PRI) has received tentative FDA approval for fluoxetine 10-mg and 20-mg tablets. In addition, its licensing partner, Dr. Reddy's Laboratories, a research-based pharmaceutical company in India, has received tentative approval for fluoxetine 40-mg capsules. A generic version of Lilly's Prozac, fluoxetine is indicated for depression, obsessive compulsive disorder, and other mental health disorders. In addition to fluoxetine 10 mg and 20 mg, three PRI generic products are on the way: Methimazole (20 mg), the generic version of King Pharmaceutical's Tapazole, indicated in the treatment of hyperthyroidism, has received final FDA approval; lisinopril, the generic form of Astra-Zeneca's Zestril, indicated in the treatment of hypertension, has tentative FDA approval; and lovastatin, the generic form of Mevacor, from Merck, has received tentative FDA approval. PRI, based in Spring Valley, N.Y., (800) 727-0923, expects final FDA approval on these products once all remaining litigation is settled.

NEW DEVICES

Injex, a disposable system using "jet injection" instead of a needle to deliver medications, has received FDA approval. Developed by Los Angeles-based Equidyne Corp., (877) 474-6539, Injex combines an ampule with a device that transmits drugs through the skin via a thin, high-pressure stream of liquid. The virtually painless injection eliminates the risk of disease from needlestick, as well as the problems and cost of disposal, according to the company.

OTC

MigraSTOP, an herbal cream that is applied to the navel to alleviate migraine pain, is being launched by Wellness Care, Wheaton, Ill., (877) 446-4472. It contains asafetida, purified water, eucalyptus oil, and menthol. At the onset of migraine symptoms, MigraSTOP should be applied to the navel and left undisturbed for 15 minutes, after which the area may be wiped and cleaned. The suggested retail price for MigraSTOP is $29.95.

United Nutrition Products, West Greenwich, R.I., has in-troduced its Cal-100 powdered calcium supplement. Containing 1,000 mg of calcium carbonate, which provides 100% of the daily RDA of the substance, each packet of the supplement can be sprinkled into any beverage or soft food. Cal-100 is available in cartons with either 30 or 60 packets. For information, call (877) 999-4664.

Mason Vitamins, Miami, (800) 327-6005, has introduced a host of new products that will boost sex drive, ease joint pain, and shape bodies. For sex drive, there's Vein Erect for men, SX Enhancer for women, and DesireX for both genders, each claiming to enhance sexual performance with such ingredients as horny goat weed and L-Arginine, a product known to increase blood flow to the sex organs. OsteoRestore formulas offer regular, maximum, and triple-strength glucosamine and chondroitin choices, and FlexiJoint formulas combine glucosamine, chondroitin, and MSM. The products are for use in relieving specific bone and joint discomfort. Bodyshapers is a set of eight different formulas to assist in fitness, depending on specific body types and weight-control needs.

Pharmavite Corp. has three new offerings. Remdex Head and Chest Formula is an all-natural product containing Andropan, a plant extract that strengthens the body's immune system. Two others, Triple Flex, containing glucosamine, chondroitin, and methylsulfonylmethane (MSM), and Joint Action, with glucosamine and SAM-e, are natural products that support joint health. Pharmavite is based in Northridge, Calif., and can be reached at (877) 866-2539.

Amerifit Nutrition has introduced and improved a cluster of prod-ucts. Soy Max Complete Meal Replacement drink mix now has a new enhanced flavor while still providing 23 vitamins and minerals plus 14 gm of soy protein, for heart health, in one drink. Estroven, an all-natural formula that balances a woman's hormones before, during, and after menopause, is now available in easy- to-swallow gelcaps. Advancing on the success of its supplement Estroven, Amerifit launched Estroven PMS, a fast-acting, natural way to control both the emotional and the phy-sical symptoms of PMS. Sootherbs Zinc, Echinacea, and Vitamin C lozenges are now available in a honey/lemon flavor, in addition to its cherry-flavored lozenge. And finally, Vitaball, a vitamin gumball that delivers 100% RDA of 11 essential vitamins—from the gum base as well as the candy coating—after five minutes of chewing will soon be hitting the market. The Bloomfield, Conn.-based firm can be contacted at (860) 242-3476.

From Novartis Ophthalmics, Atlanta, (866) 393-6336, comes GenTeal Mild, a product providing relief for mild dry eye. GenTeal Mild joins two other Novartis products—GenTeal (original formula), which treats moderate dry eye, and GenTeal Gel, which treats severe dry eye.

Aleve, a product of Bayer, Morristown, N.J., (201) 254-5000, is now available with an Easy Open Arthritis Cap. The easy-open packaging features an easy-twist, no-lock cap for those who find childproof packaging difficult to open when pain and stiffness flare up in fingers and hands. In addition to relief from arthritis pain, Aleve offers symptomatic treatment for backache, muscle aches and pains, and headache.

Home Health Care

FlexSite Diagnostics, Palm City, Fla., has unveiled a KidneyScreen At Home Kit for diabetes patients. With it, patients can collect a urine sample and mail it in a dried state to FlexSite's laboratory to determine if they have microalbuminuria, a sign of kidney problems that frequently bedevil diabetics. The kit has a suggested retail price of $26. FlexSite Diagnostics added that it will shortly trot out the Cholesterol Profile Kit—a device for measuring cholesterol levels. For more information, call (877) 212-8378.

Early Alert is an Alzheimer's home screening test kit from FMG Innovations, Scottsdale, Ariz., (866) 467-1234. Aided by 12 microencapsulated odor strips, Early Alert is a test of olfactory function. According to some medical studies, loss of the sense of smell is a significant predictor of Alzheimer's disease.

 

Judy Chi. New Product Newswire. Drug Topics 2001;15:63.