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New Product Newswire
Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, has received FDA approval for Ultracet (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets), a new centrally acting analgesic indicated for the short-term management of acute pain. Ultracet combines Ultram (tramadol hydrochloride) with acetaminophen, a combination that has been demonstrated in clinical trials to work better at managing pain than either medication alone. The drug is indicated for use in patients for five days or fewer.
Pfizer Inc. has received FDA approval for long-term use of Zoloft (sertraline HCl) in the treatment of post-traumatic stress disorder (PTSD), indicating not only the safety and efficacy of long-term use of the drug but also its importance in maintenance of the illness and preventing its relapse. According to the company, Zoloft is currently the only FDA-approved treatment for both long- and short-term PTSD. Zoloft is also indicated for major depression, panic disorder, and obsessive-compulsive disorder (OCD) in both children and adults.
Novartis Ophthalmics, Atlanta, Ga., (770) 905-1020, the eye-health division of Novartis AG, and QLT Inc., Vancouver, B.C., (604) 707-7000, have received FDA approval for Visudyne (verteporfin for injection). Visudyne is indicated for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to pathologic myopia and presumed ocular histoplasmosis. According to the companies, this is the first drug to be approved for treatment of these conditions. Visudyne was approved in April 2000 for the treatment of predominantly classic CNV caused by age-related macular degeneration (AMD).
The FDA has granted Pfizer Inc., New York City, (800) 438-1985, approval for Zyrtec-D 12 Hour (5 mg cetirizine HCl/120 mg pseudoephedrine HCl), a formulation of Zyrtec (cetirizine HCl) that includes the decongestant psedoephedrine. The product is indicated for treatment of a broad range of allergies and nasal congestion. According Pfizer, Zyrtec-D 12 Hour is the only prescription oral antihistamine/decongestant combination medicine approved to treat both year-round indoor and outdoor allergies as well as nasal congestion. It can also be safely used by patients with seasonal and year-round allergies who have concomitant mild to moderate asthma, said the company. The new product is indicated for twice-daily dosing with or without food in patients who are 12 and older. Zyrtec-D 12 Hour is marketed worldwide by the Belgian company UCB and licensed by Pfizer in the United States and Canada.
Ostex International, Seattle, (206) 292-8082, recently received Rx Home-Use clearance and CLIA Waiver status from the FDA for the Osteomark NTx Point-of-Care device, which delivers a quantitative bone breakdown result in five minutes. FDA clearance will permit the Osteomark NTx Point-of-Care device to be used by patients, with their physician's guidance. Completely disposable, it is designed to monitor bone resorption changes following initiation of osteoporosis therapy and is for use in the prevention and management of osteoporosis. The serum format of the test has been available since 1999, and the urine format since 1995. Until the recent approval, the device was available only for professional use in a physician's office.
Mylan Laboratories, Pittsburgh, (412) 232-0100, has acquired Abbreviated New Drug Application approval for the sale of butorphanol tartrate nasal spray, 10 mg/ml. Butorphanol is the generic equivalent of Bristol-Myers Squibb's Stadol NS, which is indicated for the management of pain when an opioid analgesic is appropriate. The product will be manufactured by a contract manufacturer and available for shipment from Mylan's Greensboro, N.C., distribution center.
TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is introducing two new generic products. Fluoxetine oral solution USP, 20 mg/5 ml, is AA rated and bioequivalent to Eli Lilly's Prozac. Indicated for treatment of depression and obsessive-compulsive disorder, it is available in bottles of 120 ml. Nabumetone tablets, 500 mg, are indicated for acute and chronic treatment of the signs and symptoms of osteoarthritis and rheumatoid arthritis. The tablets are AB rated and bioequivalent to GlaxoSmithKline's Relafen and are available in bottles of 100.
GTC Nutrition Co., Golden, Colo., (800) 522-4682, is introducing NutraFlora, a natural prebiotic soluble fiber that, according to the company, consists of the purest form of short-chain fructooligo-saccharides available. Such prebiotics, which occur naturally in fruits, vegetables, and grains, are natural carbohydrates that stimulate the growth of beneficial bacteria in the gastrointestinal tract. NutraFlora, derived from cane or beet sugar through a natural fermentation process, is available as a dietary supplement. The fine white powder can be sprinkled over foods or added to beverages. As little as 1 gm per day is considered an effective dose.
A generic OTC version of Merck's Pepcid AC has been made available by Dr. Reddy's Laboratories, a research-based pharmaceutical company in Hyderabad, India. The new product, famotidine tablets 10 mg, will be marketed through U.S.-based Leiner Health Products, Carson, Calif., (310) 835-8400, Dr. Reddy's supplier/ partner for OTC H2 blockers. Dr. Reddy's Laboratories received final approval of its ANDA for the product in August. Famotidine tablets 10 mg (OTC) are indicated for the treatment and prevention of heartburn associated with acid indigestion and a sore stomach.
An existing joint-care supplement line from Schiff, Salt Lake City, (801) 975-5000, now includes S-adenosyl-L-methionine (SAMe), a compound produced naturally in the body to ensure proper brain and cell function. Move Free Plus SAMe is one of the first joint-care brands to combine the natural supplements SAMe and glucosamine. It promotes joint health and emotional well-being. According to Schiff, Move Free Plus SAMe contains the recommended dosages of glucosamine (1500 mg) and SAMe (400 mg). The product has a suggested retail price of $19.99 for a 30-count package.
Another test cleared by the FDA for patient usea Thyroid Stimulating Hormone (TSH) test used to screen for thyroid diseaseis now available from Biosafe Laboratories Inc., Lake Forest, Ill., (888) 700-8378. The test was previously FDA-approved for professional use only. This TSH test was developed by Biosafe using the company's patent-pending capillary "Blood Transport System," which allows for the collection of blood in a special collection device and the shipping of a microsample (one to three drops of blood taken from the finger). All specimen processing will be performed at Biosafe's CLIA-certified laboratory in Chicago. Biosafe expects to begin shipment of the blood collection kits by mid-October.
A new blood glucose testing system employing biosensor technology has been introduced by Hypoguard, Edina, Minn., (952) 646-3200. The new Assure II Blood Glucose System allows for automatic meter calibration with a code chip. Insertion of a specially designed test strip activates the meter, which provides results in a few seconds with a blood sample as small as 3 µL.
BD Consumer Healthcare, Franklin Lakes, N.J., (201) 847-6632, plans to introduce the shortest needle ever designed for use in an insulin syringe and pen needle. The new BD Ultra-Fine II Mini Needle Syringe and BD Ultra-Fine III Mini Pen Needle can be safely and effectively used by a wide range of diabetes patients. The new BD 5-mm (3/16-in.) mini needle is 33% shorter than BD's current 8-mm (5/16-in.) short needle and 60% shorter than the 12.7-mm (1/2-in.) original needle. According to BD, the needle provides consistent, reliable insulin delivery to adults and children, and because no "pinch-up" technique is required (as when injecting insulin with the 5- mm needle), patients may find it easier to use. The needle may also help reduce needle phobia, especially among children. In addition, because diabetes therapy in the United States is moving toward more frequent but smaller daily doses of insulin, the 3/10-cc BD Ultra-Fine II Mini Needle Syringe will be BD's first syringe available with markings in 1/2-unit increments. This calibration will offer greater dose accuracy for patients who inject 30 units of insulin or less (per injection).
Clineanswers, Philadelphia, (215) 521-8511, has contracted with sister company Lippincott, Williams & Wilkins to sell its Clineguide point-of-care clinical decision support system to acute care hospitals. The product, launched in October 2000, is claimed to be the only Web-based clinical decision support tool providing hospital-based physicians with point-of-care, patient-specific drug and disease treatment advice. The evidence-based treatment guidance tailors information on a patient's unique characteristics and preexisting conditions to help improve outcomes. Teams of researchers continually update its information to include the latest guidelines and research. Direct inquiries to (800) 326-1685.
Barbara Klink. New Product Newswire. Drug Topics 2001;18:71.