new products for 2/19/01
Organon Inc., West Orange, N.J., (800) 241-8812, has received FDA approval for Cyclessa (desogestrel/ethinyl estradiol oral contraceptive), the first low-dose (less than 30 mcg of estrogen) triphasic contraceptive. Cyclessa is a 25-mcg ethinyl estradiol triphasic OC that offers cycle control comparable to that of 35-mcg ethinyl estradiol triphasic pills. The launch is planned for the first half of 2001.
Under a collaborative agreement with Enzon Inc., Piscataway, N.J., Schering-Plough Corp., Kenilworth, N.J., (908) 298-7409, has received FDA approval for PEG-INTRON (peginterferon alfa-2b) Powder for Injection. The once-weekly monotherapy, which employs Enzon's proprietary PEG technology, is indicated for the treatment of chronic hepatitis C in patients at least 18 years old with compensated liver disease and who were not previously treated with interferon. The drug is administered subcutaneously on the same day each week for one year and may be self-administered. It offers an alternative to recognized combination therapy for chronic hepatitis C. PEG-INTRON is a longer-acting form of INTRON A, a product of Schering-Plough.
Salix Pharmaceuticals, Raleigh, N.C., (919) 862-1000, has launched Colazal (balsalazide disodium), a first-line therapy approved in July 2000 for the treatment of mildly to moderately active ulcerative colitis. Balsalazide disodium is the first new chemical entity approved in 10 yearsand the first new therapy approved in seven yearsfor this indication. Colazal is approved for a course of therapy of up to 12 weeks.
Axcan Scandipharm Inc., Birmingham, Ala., (205) 991-8085, a subsidiary of Axcan Pharma, Quebec, will introduce its mesalamine suppository product Canasa in early April. The 5-aminosalicyclic acid suppositories, just approved by the FDA, were supplied by the company as a temporary emergency measure since July 1999, under the name of Fivasa. The recommended dosage is one 500-mg rectal suppository two times daily for the treatment of ulcerative proctitis.
Vivelle (estradiol trans-dermal system) estrogen-replacement patch is now available in a low-dosage formulation. The patch, which delivers 0.025 mg per day, is the size of a quarter and is obtainable by prescription in pharmacies nationwide for prevention of bone-density loss. This brings to five the number of dosage strengths available for Vivelle. The product utilizes transdermal matrix technology, delivering estradiol, the primary estrogen produced by the ovaries, through a patch that is applied twice weekly. The product is marketed by Novogyne Pharmaceuticals, Miami, (888) NOW-NOVA, a joint venture between Noven Pharmaceuticals and Novartis Pharmaceuticals. Vivelle has been available for the treatment of menopausal symptoms since March 1996, and it received FDA approval for the prevention of postmenopausal osteoporosis in August 2000.
Hoffmann-La Roche, Nutley, N.J., (973) 235-5000, has been granted FDA approval to market a new liquid formulation for the pediatric treatment indication for Tamiflu (oseltamivir phosphate). This new liquid suspension, used for the treatment of acute illness due to influenza types A and B in children one year of age and older, can also be used for adults unable to swallow a capsule. Tamiflu is the only liquid suspension approved to treat the most common strains of influenza (types A and B), according to the company.
Apotex Corp., Weston, Fla., (800) 706-5575, has been given FDA approval for chlorhexidine gluconate oral rinse USP 0.12%. The product, a generic alternative to Peridex Oral Solution, from Zila Inc., provides antimicrobial activity during oral rinsing. It is indicated for use between dental visits as part of a professional program for the treatment of gingivitis, including gingival bleeding upon probing. According to the prescribing information, chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG), nor have its effectiveness and safety been established in children under the age of 18. For patients with coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with the oral rinse should not be seen as a major indicator of underlying periodontitis.
A new generic has been added to the product roster of Synthon Pharmaceuticals, Chapel Hill, N.C., (919) 493-6006. The FDA has approved the company's ANDA for fluvoxa-mine maleate tablets in 25-mg, 50-mg, and 100-mg strengths. The new approval provides a generic alternative to Solvay Pharmaceuticals' Luvox tablets, which are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder.
For the 10% to 20% of the U.S. population that suffers from motion sickness, the FDA-approved ReliefBand is now available from Woodside Biomedical, Carlsbad, Calif., (760) 804-6900. Worn like a bracelet or watch, this drug-free, non-invasive medical device stimulates the median nerve on the underside of the wrist for relief of nausea and vomiting within minutes. Patients can adjust the strap to fit the wrist and customize the intensity level of the electronic stimulation. It can be used either before or after symptoms begin.
Available from Apothecus Pharmaceutical Corp., Oyster Bay, N.Y., (800) 227-2393, are a new brand of weight-loss aid and a new decongestant. Puralin Weight Loss Tablets and Puralin Decongestant offer alternatives to other products of their type for people with high blood pressure, diabetes, and thyroid disease, according to the manufacturer. Neither product contains phenylpropanolamine (PPA), the ingredient that had been found in numerous weight-loss aids and decongestants and recently recalled by the FDA. Instead of using allopathic ingredients (chemically stimulated symptom suppressants), the two Puralin products use homeopathic ingredients, which are said to stimulate an antibody effect by providing small, mild doses that in turn build the body's resistance against a given problem. Both products are available at a suggested retail price of $5.99 to $7.99.
Cadex Products, Ketchum, Idaho, (888) 726-8805, has introduced the Cadex medication reminder wristwatch to help patients remember to take their medications. The watch has 12 daily medication reminder alarms accompanied by a display of the medication to be taken or the medical test to be performed. A red alert button on the face of the watch provides emergency medical personnel with important personal information about the wearer, such as his/her name, medical condition, allergic reactions, doctor's name, blood type, insurance information, and Social Security number. The suggested retail price of the watch is $49.95.
A device to make opening door knobs easier is available from Maddak Inc., Pequannock, N.J., (973) 628-7600. The Ableware Door Knob Gripper is ribbed on the inner surface to firmly grip a doorknob; the outer surface is smooth to the touch. The Gripper allows the user to open a door with merely a gentle turn of the hand. It can also be used on outdoor faucets.
A new line of products is available from SlimSational Body Toning System, Santa Maria, Calif., (888) 228-9422. SlimSational Body Slimming Cream has a patented layered liposome technology to moisturize and condition the skin. According to the manufacturer, the cream's "caffeine-encapsulated formula is topically applied to help tone and firm the arms, hips, thighs, stomach, and other areas." The Collagen Protein Supplement is formulated to help the body's own mechanisms burn fat and convert it into lean body mass. The product contains collagen hydrolysate, a pure protein supplement that is made up of 20 different amino acids and peptide chains. SlimSational Facial Toning Serum is a skin exfoliant that contains vitamin C to soothe the skin plus antioxidants claimed to reduce the appearance of wrinkles. SlimSational's Firming Eye Cream contains cucumber extract and is formulated to minimize wrinkles and help the eyes look more youthful.
Fuji Photo Film U.S.A., Elmsford, N.Y., has introduced an enhanced Fujifilm QuickSnap Nexia Super Slim camera for its 24mm Advanced Photo System. The firm claims that it is the world's smallest one-time flash camera. It features a megaflash with a range of 20 feet and takes pictures in the HDTV format, providing 4 x 7-inch prints. The suggested retail price is $17.99. For more information, call (212) 704-8241.
Empyrean Bioscience, Cleveland, (216) 360-7900, has introduced a 17-oz. spray pump and 4-oz. travel-size spray version of its Antibacterial Surface Disinfectant Cleaner. The product is said to be effective against bacteria, viruses, and fungi.
An Ableware Children's Seat has been introduced by Maddak Inc. The seat weighs less than 4.5 lb., retails for $39.75, and is adjustable to two heights to grow with the child.
Barbara Klink. New Product Newswire. Drug Topics 2001;4:57.