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new products for Jan. 15, 2001
Clobevate Gel (clobetasol propionate gel, 0.05%), a new class I high-potency corticosteroid formulation, has been introduced by Stiefel Laboratories, Coral Gables, Fla., (305) 443-3800. Clobevate Gel is indicated for the short-term treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to information from the manufacturer, the new product quickly clears flare-ups by decreasing redness, swelling, and itching, helping patients to reach a point of maintenance with lower-potency topical cortico-steroids. Use of the product should be limited to two consecutive weeks, and total dosage should not exceed 50 gm per week. It should not be used on the face, groin, or axillae and is not recommended for use in children under the age of 12. It is available in a 45-gm tube.
Schering-Plough Corp., Kenilworth, N.J., (908) 298-4000, has received FDA approval to market Claritin (loratadine) Syrup 10 mg/10 ml for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause, in children two to five years of age. The company claims that Claritin Syrup is the only once-daily nonsedating antihistamine to be indicated for seasonal al-lergy sufferers as young as two years of age. The product was previously approved for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and the treatment of CIU in patients six years of age or older. The recommended dose for children age two to five years is one tsp. (5 mg) once daily; the recommended dose for patients age six and older is two tsp. (10 mg) once daily.
TAP Pharmaceutical Products has received FDA approval for an indication for healing and risk reduction of NSAID-associated gastric ulcers for its proton pump inhibitor Prevacid (lansoprazole). Prevacid decreases the production of stomach acid by blocking the tiny pumps responsible for acid secretion, allowing patients to continue necessary NSAID treatment. The new indication builds on Prevacid's already substantial list of indications, among them the treatment of symptomatic gastroesophageal reflux disease (GERD); treatment of active benign gastric ulcers; treatment and maintenance of duodenal ulcers; treatment and maintenance of erosive esophagitis; and treatment and maintenance of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Lake Forest, Ill.-based TAP, (800) 621-1020, is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries Ltd., of Osaka, Japan.
The FDA has granted marketing approval to Schering-Plough, Kenilworth, N.J., for Lotrisone (clotrimazole and betamethasone dipropionate) in a lotion formulation. The topical drug is indicated for treatment of symptomatic inflammatory tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. The combination antifungal and corticosteroid was first approved by the FDA in 1984 in a cream formulation, which went off patent in October 2000.
Alza Corp., Mountain View, Calif., (650) 564-5222, has received FDA approval for 54-mg Concerta (methylphenidate HCl) extended-release tablets. Approval of the new dosage option will thus provide physicians with three strengths of Concerta, indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The new once-a-day methylphenidate treatment for ADHD lasts through 12 hours in patients age six years and older. Concerta uses an advanced OROS patterned-release delivery system, which has been employed safely for nearly 20 years in numerous Rx and OTC medications taken by both adults and children. Concerta is also available in 18- and 36-mg strengths.
A new 69-count box of individually wrapped Clindets 1% (clindamycin phosphate pledgets)equivalent to 1% clindamycin (10 mg/ ml)is available from Stiefel Laboratories, Coral Gables, Fla., (305) 443-3800. Previously, the product had been packaged with 60 pledgets per box. Clindets, indicated in the treatment of acne vulgaris, contains the most widely prescribed topical antibiotic for the treatment of acne. Topical clindamycin is considered a useful therapy for superficial, pustular acne when used alone or with other treatments. Each single-use pledget delivers approximately 1 ml of clindamycin phosphate topical solution.
TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, has received FDA approval to manufacture nifedipine extended-release tablets, 60 mg, in bottles of 100. The product, which is AB-rated and said to be bioequivalent to Bayer's Adalat CC, is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Nifedipine extended-release tablets are also available in 30-mg strength.
Mylan Laboratories, Pittsburgh, (412) 232-0100, has received FDA approval for its abbreviated new drug application (ANDA) for fluvoxamine maleate tablets in 25-, 50-, and 100-mg strengths. Fluvoxamine maleate 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.
Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories Ltd., Princeton, N.J., (609) 720-9200, has been granted approval from the FDA to market three anti-infective products. Approval was provided for minocycline hydrochloride in 50-mg, 75-mg, and 100-mg capsules. Minocycline HCl is a broad-spectrum bacteriostatic anti-infective agent indicated for the treatment of multiple strains of bacterial infections with a twice-daily dosage. This approval represents the first offering by a generic manufacturer of all three dosage strengths, each of which is claimed to be bioequivalent and AB-rated to Lederle's Minocin. Ranbaxy will offer a wide range of packaging, including bottles of 100 and bulk bottles of 500. In addition, unit dose packaging will be available in the institutional market ... Doxycycline monohydrate, available in 50-mg and 100-mg capsules, is a broad-spectrum tetracycline antibiotic indicated for a wide range of bacterial infections. The AB-rated product is said to be bioequivalent to Monodox, from Oclassen Dermatologics ... Ranbaxy will also manufacture and market its broad-spectrum anti-infective Amoxicillin, available in 500-mg and 875-mg tablets and in 200-mg and 400-mg chewable tablets, for a twice-daily dosage regimen. Ranbaxy claims to be the first generic manufacturer to be granted approval for a chewable form. The branded drug, Amoxil, is a registered trademark of SmithKline Beecham Pharmaceuticals.
A new chewable probiotic dietary supplement is now available from McNeil Consumer Healthcare, Fort Washington, Pa., (215) 273-7000. Probiotica contains Lactobacillus reuteri cells, which are naturally occurring bacteria present in the human gastrointestinal tract. Each lemon-flavored chewable tablet of Probiotica contains 100 million of these cells, which are believed to promote digestive health. Probiotica is licensed from the Swedish company BioGaia Biologics.
CalSure, a new calcium supplement, is now available from Rexall Sundown, Boca Raton, Fla., (561) 241-9400. It offers consumers a unique formula that contains patented Calcium Citrate Malate, a highly absorbable source of calcium that is said to be more effective than calcium carbonate and even more absorbable than the calcium in milk. The CalSure formulation combines Calcium Citrate Malate and vitamin D for enhanced absorption. Each caplet provides 25% of the recommended daily requirement for vitamin D and calcium. CalSure is available in 80- and 140-caplet bottles.
L'Oreal, New York, N.Y., (212) 984-4109, has introduced L'Oreal Kids Moisturizing Bath & Shower Gel. The product comes in brigh-colored shark-shaped bottles in normal, delicate, and dry skin formulas.
Cetaphil Daily Facial Cleanser for Normal to Oily Skin is now available, renamed to make it clear that the product is suitable for combination skin, oily T-zones, and acne-prone and oilier skin types. The cleanser comes in an 8-oz. pump dispenser and retails for $6. The manufacturer is Galderma Laboratories, Fort Worth, (817) 263-2600.
Revlon Realistic Extra Conditioning Crème Relaxer System is sporting new packaging for its four formulations: fine and colored hair, normal hair, coarse hair, and sensitive scalps. Revlon Professional Products Worldwide was recently acquired by the Colomer Group, a global firm with U.S. headquarters in New York City. For more information, call (800) 933-4303.
Barbara Klink. New Product Newswire. Drug Topics 2001;2:81.