TAP Pharmaceuticals, Lake Forest, Ill., (800) 621-1020, has been granted FDA clearance to market its new cephalosporin antibiotic, Spectracef (cefditoren pivoxil). The oral agent, available in a 200-mg tablet, is indicated to treat acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis, and uncomplicated skin and skin structure infections. TAP Pharmaceuticals is a joint venture between Takeda Chemical Industries of Japan and Abbott Laboratories.
Bertek Pharmaceuticals, Research Triangle Park, N.C., (888) 5-BERTEK, has obtained a fourth indication for its Mentax (butenafine HCl) topical antifungal cream. As well as treating tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm), Mentax is now approved for treating tinea versicolor, a fungal infection of the skin due to Malassezia furfur. The recommended dosing for tinea versicolor is once daily for two weeks.
Marketing approval has been granted to Genentech Inc., South San Francisco, (650) 225-7848, for its thrombolytic agent, Cathflo Activase (alteplase). The tissue plasminogen activator (t-PA) is indicated for the restoration of function to central venous access devices that have become occluded. Cathflo Activase will be marketed using a different dose and dosing regimen from the company's own Activase (alteplase) product, which is indicated for use in the management of acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. According to the company, the new product will be offered in a 2-mg single-patient-use vial and is the only thrombolytic available for this indication.
Barr Laboratories, having successfully launched the first generic capsule version of Eli Lilly's antidepressant Prozac (fluoxetine HCl) 20 mg, has received tentative approval to manufacture and market fluoxetine hydrochloride tablets, USP 10 mg. The Pomona, N.Y.-based company, (845) 348-6808, expects to receive final approval to market the 10-mg tablet--as well as its 10-mg capsule product that was tentatively approved in June 2000--when the generic exclusivity for the brand counterparts expires in February 2002.
Gensia Sicor Pharmaceuticals, a wholly owned subsidiary of Sicor Inc., Irvine, Calif., (949) 455-4879, has been granted ANDA approval for haloperidol lactate. The drug provides a generic equivalent to Ortho-McNeil's Haldol, which is indicated for use in the management of manifestations of psychotic disorders.
Able Laboratories is set to launch three formulations of the appetite suppressant phentermine HCl. FDA approval allows the South Plainfield, N.J.-based company, (888) 826-ABLE, to introduce a generic version of TEVA's 37.5-mg Adipex-P tablet, as well as the 30-mg capsule and beaded capsule versions made by Eon Labs. The products are indicated as a short-term adjunct in a regimen of weight reduction, exercise, behavioral modification, and calorie restriction.
Hoping to stem recent outages, Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories Ltd., Princeton, N.J., (609) 720-9200, has received FDA approval to market cephalexin for oral suspension. The cephalosporin antibiotic is bioequivalent to Eli Lilly's Keflex for Oral Suspension and will be available in 125 mg/5 ml and 250 mg/5 ml strengths in both 100-ml and 200-ml bottles. Arrival in retail pharmacies is expected during the third quarter of 2001.
Eon Labs has begun the shipping of flutamide, USP capsules, the generic equivalent of Schering Corp.'s Eulexin, which treats prostate cancer. Eon's version will also be packaged in 180- and 500-count bottles and 100-count unit-dose packages, same as the brand forms. Eon Labs can be reached at (800) 526-0225, Laurelton, N.Y.
Relief will soon be available for cold sore sufferers with the introduction of Orajel Multi-Action Cold Sore Medicine, from Del Pharmaceuticals, Uniondale, N.Y., (516) 844-2020. The new product offers a combination of ingredients, including two pain relievers and three skin protectants, as well as vitamins A, D, and E, which the company claims will provide fast, effective relief from the pain, cracking, and itching often associated with cold sores.
From Colgate Oral Pharmaceuticals comes relief from canker sore pain. The New York, N.Y.-based company, (800) 962-2345, has launched Colgate Orabase Soothe-N-Seal canker and mouth sore treatment. The product works by sealing off nerve endings and creating a protective barrier over the affected area that stays in place for up to six hours. It uses the same patented medical bioadhesive technology that is currently used in hospitals as an alternative to traditional sutures for wound closure. The suggested retail price is $9.99.
Bayer's Consumer Care Division, Morristown, N.J., (973) 254-5000, is set to roll out Alka-Seltzer Morning Relief. According to company information, this will be the first nationally available product promoted specifically for morning headache and fatigue associated with a hangover. Each effervescent citrus-flavored tablet contains 500 mg of aspirin and 65 mg of caffeine. The suggested retail price for a 12-count package will be $3.69; $4.69 for a 24-count package.
To help improve patient compliance, Toledo, Ohio-based Owens-Brockway Prescription Products, (419) 247-1297, is rolling out the Remind Cap closure. This new cap for prescription packages, which emits visual and audible alerts, is preset by the pharmacist to remind patients to take their medication. Remind Cap Ltd., developer and manufacturer of the product, has given Owens-Brockway exclusive distribution rights.
United Pacific, Columbia, S.C., (803) 735-0034, has expanded its knee pain relief support line with the addition of two new products. The new Thermoskin Knee Wrap Stabilizer has been designed to be user friendly and durable for those patients who are suffering chronic pain. It utilizes a popliteal cutout at the back of the knee to give maximum comfort while it maintains knee stability. The company has also developed a Thermoskin Hinged Knee Wrap. The brace, which can be fitted with single pivot, dual pivot, and range of motion hinges, allows the user to decide how much movement should be attained, with each hinge allowing for a different type of motion.
The Ableware Double AbleRise Bed Rail is positioned on both sides of a bed to assist patients in getting in and out of bed, repositioning and turning in bed, and to help prevent falls. Introduced by Maddak Inc., Pequannock, N.J., (973) 628-7600, the bed rail handles provide a convenient storage area for keeping personal items within arm's reach. Rails fit twin, full, and queen-size beds. The suggested retail price is $145.
Blistex Inc., Oak Brook, Ill., (312) 372-7090, is offering consumers an alternative to lip-gloss with Blistex Silk and Shine. The new lip balm combines silk extracts with special moisturizers; vitamins A, B5, and E; amino acids; and a light, glossy finish to add conditioning, moisturizing, and smoothing benefits. Each 0.13- oz. stick of Blistex Silk and Shine has an expected retail price of $2.49.
Naturistics, a division of Del Pharmaceuticals, Uniondale, N.Y., (516) 844-2020, has unveiled a wide array of stocking stuffers and grab bag items for the holiday season. Included in the collection is a variety of eye, lip, and body frostings with names like Bright Wishes, Tinsel Totes, Glitter 'N Glam Glitter Stixx, and Lip Lites Lip Gloss. The products range in price from $2.50 to $4.95 each.
Tammy Chernin. New Product Newswire. Drug Topics 2001;19:65.