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New products (Rx, OTC, HHC, HBC, ETC.) for the Aug. 23, 2004 issue of DRUG TOPICS.
For the treatment of moderate to severe scalp psoriasis, Galderma Laboratories, Fort Worth, (817) 961-5000, is now launching Clobex (clobetasol propionate) Shampoo, 0.05%. The super-high-potency corticosteroid, applied to scalp lesions once daily for four consecutive weeks, should be used only by patients 18 years of age and older.
EstroGel (estradiol gel), from Solvay Pharmaceuticals, Marietta, Ga., (770) 578-9000, approved earlier in the year, is now cleared for marketing. According to the company, it is the first transdermal estrogen gel to be sold in the United States and is indicated to treat moderate to severe hot flashes and moderate to severe dryness, itching, and burning in and around the vagina. The hydro-alcoholic gel provides continuous delivery of the medication through once-daily application on one arm from wrist to shoulder. Each non-aerosol, metered-dose pump delivers 64 1.25-gm daily doses.
Approval for Alinia for Oral Suspension, from Romark Laboratories, Tampa, Fla., (813) 282-8544, now includes an indication for treating patients 12 years of age and older who have diarrhea caused by Giardia lamblia. The oral suspension of nitazoxanide was already approved for children ages one to 11 years in the treatment of Cryptosporidium parvum and Giardia lamblia.
Botulinum Toxin Type A (Botox) has been approved to treat severe underarm sweating, or primary axillary hyperhidrosis, that is unmanageable even by prescription antiperspirants. When a small dose is injected, it stops the release of acetylcholine, temporarily blocking the nerves in the underarm that stimulate sweating. Its manufacturer is Allergan Inc., Irvine, Calif., (714) 246-4500.
Pfizer Inc., New York City, (800) 438-1985, has received pediatric exclusivity for IV Camptosar (irinotecan hydrochloride). Camptosar is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic colon or rectal carcinoma whose disease has recurred or progressed following initial fluorouracil-based therapy.
Romark Laboratories, has received approval for Alinia (nitazoxanide) Tablets. This tablet formulation of the antiprotozoal drug is indicated for treating patients 12 years and older who have diarrhea caused by Giardia lamblia.
The FDA has approved a liquid formulation of Synagis (palivizumab) for MedImmune Inc., Gaithersburg, Md., (877) 633-4411. The monoclonal antibody was approved in 1998 to prevent serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk for RSV disease.
ISTA Pharmaceuticals, Irvine, Calif., (949) 788-6000, is launching ISTALOL, a once-daily topical solution of timolol, in the United States. The beta-blocking agent is indicated for the treatment of glaucoma.
Axid (nizatidine) Oral Solution is now available from Reliant Pharmaceuticals, Liberty Corner, N.J., (908) 580-1200. The approval offers pediatric patients age 12 and older a treatment for endoscopically diagnosed esophagitis (including erosive and ulcerative esophagitis) and associated heartburn due to gastroesophageal reflux disease for up to 12 weeks. Axid capsules were approved earlier.
Axcan Pharma, Quebec, (450) 467-5138, received approval from the FDA for the use of URSO (ursodiol) in a 500-mg tablet. This stronger dosage form is to be administered two to four times daily for the treatment of primary biliary cirrhosis, which can lead to cirrhosis and ultimate liver failure.
A number of companies have received approval for their fluconazole offerings. TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVAUSA; Mylan Laboratories, Pittsburgh, (724) 514-1800); Par Pharmaceutical, Woodcliff Lake, N.J., (800) 828-9393; and Pliva Inc., East Hanover, N.J., (800) 922-0547 (formerly Sidmak), are introducing flu- conazole tablets in 50-, 100-, 150-, and 200-mg strengths. TEVA is also cleared to market fluconazole injection 200 mg/100 mL and 400 mg/200 mL. Pliva's tablets will be available in bottles of 30 and 100; the 150-mg strength tablet is available in blisterpacks of one tablet per card, packed in units of 12 cards.
Roxane Laboratories, Columbus, Ohio, (614) 272-4774, has approval for fluconazole tablets in 100- and 200-mg strengths in bottles of 30, 10 x 10 unit-dose packages, and a 150-mg unit of 12 cards of one tablet each; Roxane also has approval for fluconazole for oral suspension 10 mg/ mL and 40 mg/mL, available in 35-mL bottles. Ranbaxy Pharmaceuticals, Jacksonville, Fla., (888) RANBAXY, will manufacture and market fluconazole tablets in 50-, 100-, 150-, and 200-mg strengths and fluconazole for oral suspension in 10 mg/mL (50 mg/5mL) and 40 mg/mL (200 mg/5 mL). Mayne Pharma (USA), Paramus, N.J., (201) 225-5500 (formerly Faulding), has approval for fluconazole injection mini bags for use in the hospital arena. Mayne will be making fluconazole injection (2 mg/mL) in 0.9% sodium chloride injection available in 10-packs of 200 mg/100 mL and 400 mg/200 mL mini bags. Hospira Inc., Lake Forest, Ill., (847) 937-6100, is bringing out its own FirstChoice fluconazole premix for injection. Fluconazole offers a generic equivalent to Pfizer's Diflucan, indicated for treating fungal infections, among them vaginal candidiasis, pharyngeal and esophageal candidiasis, and cryptococcal meningitis.
Kali Laboratories, Somerset, N.J., (732) 537-0400, a subsidiary of Par Pharmaceutical, has final FDA approval for nystatin topical powder (100,000 units/gm). The antibiotic is indicated to treat diaper rash associated with bacterial, yeast, or fungus infections. The branded drug, Mycostatin, is a product of Westwood-Squibb.
Alamo Pharmaceuticals, Beverly Hills, Calif., (310) 859-7799, has a new orally disintegrating clozapine tablet for the management of severely ill schizophrenic patients recalcitrant to standard drug treatment for their condition. FazaClo, a new mint-flavored tablet, offers a substitute for Novartis' Clozaril on a milligram-for-milligram basis.
Two new generics have been approved for Able Laboratories, South Plainfield, N.J., (908) 754-2253. Bethanechol chloride tablets, USP, 5, 10, 25, and 50 mg, a therapeutic equivalent to Odyssey Pharmaceuticals' Urecholine Tablets in the same strengths, are indicated for acute postoperative and postpartum non-obstructive urinary retention and for neurogenic atony of the urinary bladder with retention. Hydroxyzine hydrochloride tablets, USP, 10, 25, and 50 mg, the therapeutic equivalent of Pliva Inc.'s hydroxyzine hydrochloride tablets in the same strengths, are used in the treatment of anxiety and tension associated with psychoneurosis and the management of pruritus due to adverse allergic reactions.
Able Laboratories, South Plainfield, N.J., (908) 754-2253, has FDA approval for promethazine hydrochloride tablets, USP, in 12.5-, 25-, and 50-mg strengths. According to Able, it is the only firm cleared to market all strengths of the drug, which is the therapeutic equivalent to Wyeth's Phenergan. Promethazine HCl, an H1 receptor agonist, is indicated as an antihistamine, a sedative, and an antiemetic.
The FDA has given tentative approval to Barr Laboratories, Woodcliff Lake, N.J., (201) 930-3300, for a generic version of Aventis Pharmaceuticals' Allegra-D. Fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg extended-release tablets are indicated for relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older.
Eon Labs, Laurelton, N.Y., (718) 276-8607, has final FDA approval for midodrine hydrochloride tablets in 10-mg strength. The drug offers a generic alternative to ProAmatine tablets, from Shire. Midodrine HCl is used for the treatment of symptomatic orthostatic hypotension.
WellSpring Pharmaceutical Corp. has received FDA approval to market bethanechol chloride in the United States as a generic alternative to Urecholine, from Odyssey. By a licensing agreement with WellSpring, the drug will be available from Abrika Pharmaceuticals, Sunrise, Fla., (954) 315-6600, in 10- and 25-mg strengths, for the management of urinary tract and bladder disorders. The 50-mg strength is expected to be forthcoming shortly.
Atrix Laboratories, Fort Collins, Colo., (970) 482-5868, has received tentative FDA approval for mometasone furoate cream, USP, 0.1%. The medium-potency dermatologic cream, which will provide a generic alternative to Schering-Plough's Elocon Cream, is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
For faster-acting relief for swimmer's ear, Star Pharmaceuticals, Fort Lauderdale, (800) 845-7827, is introducing an improved physician's formula of Star-Otic Ear Solution, with more bacteria-fighting protection. Use of the solution before and after water exposure can effectively prevent the occurrence of otitis externa, according to the company.
New from Reese Pharmaceutical Co., Cleveland, (216) 231-6441, is Refenesen expectorant, a single-ingredient guaifenesen tablet for relief of chest congestion and cough. The 200-mg tablet is safe for use in children ages six to 12 years. The product is available in both bottle and box.
Israel-based Se-cure Pharmaceuticals Ltd., (877) 336-2735, is introducing a new nonhormonal dietary supplement for relief of menopausal symptoms and enhancement of bone mineral density. Made from a tofu-derived compound as well as ground flaxseed, and described as a phyto-selective estrogen receptor modulator, Femarelle relieves hot flashes, headaches, and joint and muscle discomfort.
For enhanced intestinal health, one can look to Probio-Tec AB-tab-4 tablets, from Chr. Hansen Inc., Milwaukee, (800) 558-0802. The formulation contains two probiotic cultures, LA-5 Lactobacillus acidophilus and BB-12 Bifidobacterium for strengthening, maintaining, and restoring the intestinal microflora.
PonchoVest is a convenient, new aid for safe, easy handling of wheelchair patients. From LiftVest, New York City, (800) 300-5671, the garment provides multiple webbing handholds that offer a caregiver secure grips for lifting, transferring, or positioning of wheelchair patients, thus reducing the risk of injury to both caregiver and patient.
The Clearblue Easy Easy-Read Ovulation Test is now available from Inverness Medical Innovations, Waltham, Mass., (781) 647-3900. The company claims it is the first digitally read ovulation prediction test, providing a "nonambiguous" indication of the luteinizing hormone surge that precedes ovulation.
Toward greater consumer control over heart health through home testing, Lifestream Technologies, Post Falls, Idaho, (877) 457-9409, is introducing a cholesterol monitor that enables consumers to calculate their personal cardiovascular risk. A full health-risk assessment is available based on a three-minute cholesterol reading and eight other factors: weight, height, age, gender, diabetic status, smoker/nonsmoker, blood pressure, and HDL score.
Abbott Laboratories has what it says is the first home glucose monitor that enables diabetes patients to test for both blood glucose and ketone levels. The Precision Xtra, designed to prevent blood sampling errors and minimize the effects of interfering substances such as aspirin, vitamin C, and acetaminophen, has a 450-test memory with seven-, 14-, and 30-day averaging results downloadable to a personal computer.
To its Healthy Living line of consumer home healthcare products, Samsung Healthcare, a division of Samsung America, Ridgefield Park, N.J., is adding a 10-second thermometer series for oral, rectal, or axillary use. The digital stick thermometers will be offered in three models: rigid, flex tip, and bendable tip. For further information, call (800) 261-0130.
SciVolutions, Stoughton, Mass., (800) 969-2883, has added Doctor's Choice Blister Treatment to its line of wound care products. A hydrocolloid gel in the sterile heel bandage creates a humid environment to restore the skin's natural moisture level. The bandage absorbs excess fluids, allows evaporation of excess moisture, and repels water, dirt, and germs.
Breakthrough Engineered Nutrition, Tampa Bay, Fla., (727) 544-8866, is launching seven new products: six CarbSlim offerings and one Lean Protein item. In addition, WalMart has accepted two CarbSlim items for chainwide distribution: Chocolate Caramel Crunch Bites and Chocolate Chip Cookie Dough Bites. The net- carb-free candies are geared to a low-carbohydrate lifestyle.
Nancy Jillard. New Product Newswire. Drug Topics Aug. 23, 2004;148:84.