New Product Newswire

July 16, 2001

New Rxs, OTCs, HHCs, etc.

 

NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Organon's low-dose oral contraceptive Cyclessa (desogestrel/ethinyl estradiol) is now available. Providing 25 mcg of estrogen (ethinyl estradiol) per day for 21 days, the triphasic birth control pill carries the lowest estrogen dose of its kind in the United States, claims the West Orange, N.J., firm. The Cyclessa cycle pack also contains a daily progestin dose of 100 mcg of desogestrel for days one to seven, 125 mcg-150 mcg for days eight to 14, and 15 to 21, respectively. The last week of the cycle contains placebo pills. Organon reported that women on Cyclessa experienced less breakthrough bleeding than those on triphasic oral contraceptives yielding a higher estrogen dose. The company can be reached at (800) 631-1253.

Genzyme General has relaunched its 800-mg tablet formulation of Renagel (sevelamer hydrochloride). This dosage was out of stock temporarily early this year, and patients were shifted to an equivalent dose of 400-mg Renagel tablets or 403-mg Renagel capsules. Thanks to increased production by the Cambridge, Mass., firm, the 800-mg formulation is once again available. The drug is indicated for reduction of serum phosphorus in patients with end-stage renal disease who are on hemodialysis. For information, call (800) 745-4447 or (800) 847-0069.

Medicis Pharmaceutical Corp. has introduced Alustra (hydroquinone USP 4%) to treat ultraviolet-induced skin discolorations as well as hyperpigmentation associated with pregnancy, minor trauma, and the use of oral contraceptives and hormone replacement therapy. Besides hydroquinone, the drug also contains retinol (a vitamin-A derivative), an antioxidant complex, and glycerin. The Scottsdale, Ariz., firm can be reached at (800) 550-5115.

NEW INDICATION

First approved for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), Protonix Delayed-Release Tablets (pantoprazole sodium) now can be used for maintenance of healing of erosive esophagitis and reduction in relapse rates of both daytime and nighttime heartburn symptoms in GERD patients. In two double-blind studies, Protonix 40 mg maintained healing of erosive esophagitis in 86% of patients at 12 months and relief from daytime and nighttime heartburn 90% of the time. The proton pump inhibitor is marketed by Wyeth-Ayerst Laboratories, a division of American Home Products Corp., Madison, N.J., (973) 660-5000.

NEW DELIVERY SYSTEMS

Pari Respiratory Equipment has developed the Proneb Ultra, a compressor that delivers aerosolized medications and is to be used with the Pari LC Plus and the Pari LC Star Reusable Nebulizers. The Monterey, Calif., firm claims the device can reduce treatment time for patients with respiratory diseases to as little as five minutes and deliver a higher percentage of medication into the patients' lungs, minimizing waste of aerosol medicine. The Proneb Ultra weighs only four pounds and is available in models for adults and children. For information, call (800) 327-8632.

GlaxoSmithKline's hepatitis A and B pediatric vaccines will soon be available in Safety Tip-Lok form. This all-in-one delivery system consists of a prefilled syringe with a peel-off label for recording lot number and expiration date, along with BD SafetyGlide Needles for pe-diatric doses of Havrix (hepati-tis A vaccine, inactivated) and Engerix-B (hepatitis B vaccine [recombinant]). The Philadelphia firm claims that Safety Tip-Lok meets the Occupational Safety & Health Administration's standard for protecting people from needlestick injuries. For information, call (888) 825-5249.

NEW GENERICS

Fougera has started shipping clotrimazole and betamethasone dipropionate cream USP 1%/0.05%. As an antifungal/corticosteroid, the cream is AB-rated to Schering/Key's Lotrisone. The combination agent is indicated for the topical treatment of skin infections caused by fungus, such as athlete's foot, jock itch, or ringworm. The generic cream comes in 15-gm and 45-gm tubes. For information, call the Melville, N.Y., firm at (800) 645-9833.

Bedford Laboratories has rolled out two new products. Haloperidol injection USP, a generic equivalent to Ortho-McNeil's 000, 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. 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.,

 

Judy Chi. New Product Newswire. Drug Topics 2001;14:52.