NEW PRODUCT NEWSWIRE

Rx

NEW FORMULATION

An injectable form of an existing medication is now available for rapidly controlling agitated behavior and psychotic symptoms, such as hallucinations and delusions, in patients with acute exacerbations of schizophrenia. Geodon for Injection (ziprasidone mesylate) is an atypical antipsychotic for intramuscular use, said to be the first such medication approved in the United States. Geodon, a serotonin and dopamine antagonist, is already available in an oral formulation from Pfizer Inc., New York City, (800) 438-1985.

NEW DOSAGE

Barr Laboratories, Pomona, N.Y., (800) BARRLAB, has received approval for Cenestin (synthetic conjugated estrogens, A) in a new 0.3-mg strength tablet. The plant-derived product is indicated for the treatment of vulvar and vaginal atrophy associated with menopause. Barr currently markets Cenestin in 0.625-, 0.9-, and 1.25-mg tablets.

A new, intermittent-dosing option has been FDA-approved for Sarafem (fluoxetine hydrochloride), from Eli Lilly & Co., Indianapolis, (800) 545-5979. The selective serotonin reuptake inhibitor can now be taken every day or only during the luteal phase of the menstrual cycle for treatment of premenstrual dysphoric disorder (PMDD). Sarafem is packaged in a box of four seven-day blister packs to help patients track their own adherence to the treatment regimen.

Wellbutrin SR tablets (bupropion hydrochloride), from GlaxoSmithKline, Philadelphia, (888) 825-5249, are now approved in 200-mg sustained-release strength for treatment of depression. The new approval joins the existing strengths of 100 mg and 150 mg.

NEW PACKAGING

An optional new Ortho Personal Pak tablet dispenser is available in limited edition with each prescription for the contraceptive Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) tablets. The two new designs, Red High Heels and Zebra Kiss, can be ordered at (866) 221-1031, or on-line at www.orthotricyclen.com. Ortho Tri-Cyclen is a product of Ortho-McNeil, Raritan, N.J., (800) 682-6532.

NEW GENERICS

Barr Laboratories has begun shipping generic versions of Wyeth's Triphasil tablets and Berlex's Tri-Levlen tablets, as well as Wyeth's Nordette tablets ­ 28-day regimen. All are levonorgestrel and ethinyl estradiol oral contraceptives. Tri-Phasil and Tri-Levlen will bear the trademark name of Enpresse; Nordette will carry the Portia trade name.

Impax Laboratories, Hayward, Calif., (510) 476-2000, has provisional approval to market a generic version of Claritin (loratadine), an antiallergy drug from Schering-Plough.

Tramadol hydrochloride tablets, 50 mg, have been approved for Watson Pharmaceuticals, Corona, Calif., (909) 493-5611; for TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA; for Purepac Pharmaceutical Co., Elizabeth, N.J., (908) 527-9100; for United Research Laboratories/Mutual Pharmaceutical, Philadelphia, (800) 523-3684; and for Caraco Pharmaceutical, Detroit, (313) 871-8400. Indicated for managing moderate to moderately severe pain, this synthetic opioid analgesic offers a generic alternative to Ortho-McNeil's Ultram tablets.

Morton Grove Pharmaceuticals, Morton Grove, Ill., (847) 967-5600, has marketing approval for carbamazepine oral suspension, USP, 100 mg/5 mL. The anticonvulsant drug is indicated for partial seizures, generalized tonic-clonic seizures, and mixed seizure patterns. The new approval provides a generic alternative to Novartis' Tegretol Oral Suspension, 100 mg/5 mL.

OTC

FlexAgility is a proprietary herbal extract for use in helping reduce the pain and stiffness of arthritis and rheumatism. Available from Enzymatic Therapy, Green Bay, Wis., (920) 469-1313, this patented blend of ginger (Zingiber officinale) and greater galangal (Alpinia galanga) is said to inhibit the enzymes that cause pain and stiffness yet not cause any gastrointestinal side effects.

New from Gebauer Co., Cleveland, (800) 321-9348, is a skin refrigerant for quick relief of minor back pain, sprains, and strains. Gebauer's Instant ICE, nonflammable and non-ozone depleting, can also be used for first aid in minor sports injuries and for swelling due to bruising and contusions.

Norexin, a proprietary blend of ephedrine and caffeine from BioTech Corp., Glastonbury, Conn., (800) 774-3664, may be able to help people who are overweight lose pounds safely without undue side effects. The all-natural supplement helps increase metabolism and suppress appetite while blocking fat cell storage. The addition of anti-jitter nutraceuticals to the blend prevents the nervousness caused by other weight-loss products.

Home Health Care

Roche Diagnostics, Indianapolis, (317) 845-2000, has FDA clearance for its new Accu-Chek Pocket Compass diabetes care software. The software helps in the management of the disease by tracking trends in blood glucose levels as it stores and analyzes up to 1,000 blood glucose readings. The software, which works on handheld computers running the Palm OS Platform, provides up to 15 customizable reports, graphs, and charts, thereby helping health providers translate the data into treatment decisions.

For a glucose monitoring system that is integrated into a personal digital assistant, TheraSense Inc., Alameda, Calif., (510) 749-5400, has introduced the FreeStyle Tracker diabetes management system. Available for use with the Handspring Visor PDA, it enables patients to test for blood glucose levels, get a read on the PDA screen, graph and chart results, track food intake, etc., enabling physicians to tailor treatment recommendations more accurately.

Health & Beauty Care

From Stassi Cosmetics, San Diego, (858) 720-1730, comes a nationwide launch of individual 0.5 fl.-oz. single-use foil packets of SPF to go Moisturizing Sunscreen Lotion. Available in SPF levels of 8, 15, 30, and 45, this nongreasy, water-resistant, hypoallergenic sunscreen provides long-lasting, broad-spectrum UVA/UVB protection with Z-Cote transparent zinc oxide. Vitamin E, tea tree oil, aloe extract, and soluble collagen enrich and further protect the skin. In addition, the company offers SPF to go 2- and 4-oz. tubes of the moisturizing lotion, SPF to go for Kids, SPF to go "Solar Ice" SPF 15 Lip Balm, and SPF to go "Cool Skin" After Sun Moisturizer.

Rite Aid Corp., Camp Hill, Pa., has launched 411: Hair Info, a salon-style hair care line, at its stores nationwide. The 14-item product line features shampoos, conditioners, and styling aids that include curl crème, straightening serum, and hydrating styling crème. The Hair Info toll-free line, (877) 4-411-INFO, is open Monday through Friday, 8 a.m. to 5 p.m. Central Time. A Web site—www.411hairinfo.com—is also available for styling and product information.

Etc.

Med Time Technology, Boca Raton, Fla., (561) 391-3952, is offering an easy-to-use medication compliance cap that measures the elapsed time between medication dosages. An alarm, built into The Pill Timer, reminds consumers to take their medication and automatically resets with each use. The device fits prescription vials, meets USP safety standards, and includes a missed-dosage alarm and indicator with a large, easy-to-read display.

CAS Medical Systems, Branford, Conn., has acquired from its developer the BiliBottoms phototherapy diaper line for use primarily in neonatal intensive care units. BiliBottoms is a patented, light-permeable design that provides for maximum exposure of the skin surface to phototherapy as a way to shorten treatment time and allow a faster reduction of bilirubin levels in newborns. The diaper has a latex-free nonwoven front sheet and a clear poly back sheet with an absorbent core padding. For further information, call (203) 315-6311.

For patients on multiple medications, Taylored Enterprises, North Andover, Mass., (978) 681-9969, has introduced two new items to its Easy Minder reusable lists. The MediMinder Plus provides space for listing 10 medications, their dosages, and instructions for administration for one person. MediMinder Plus 2 offers the same chart, but for use by two people. The reverse side of each chart has room for recording medical, family, and emergency contact information.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;14:49.