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The FDA has granted Ascent Pediatrics, Wil-mington, Mass., (773) 528-9010, marketing approval for Orapred (prednisolone sodium phosphate 20.2 mg/5 ml, equivalent to prednisolone 15 mg/5 ml) oral solution. The product, a dye-free, grape-flavored oral solution, is indicated for treatment of children with asthma and other inflammatory conditions.
Two new indications have been approved for Astelin Nasal Spray (azelastine HCl), from Wallace Laboratories, Cranberry, N.J., (800) 526-3840. The product can now be used for treatment of nonallergic vasomotor rhinitis in patients 12 years of age and older and for treatment of seasonal allergic rhinitis in children five years and older. According to the company, Astelin Nasal Spray is now the only second-generation antihistamine indicated for both conditions.
The FDA has granted marketing approval for CellCept (mycophenolate mofetil) for the prophylaxis of acute rejection in pediatric renal transplant patients. The approval includes three oral formulations of the drug: a 250-mg capsule, a 500-mg tablet, and an oral solution in 200 mg/ml strength. The drug, from Roche Laboratories, Nutley, N.J., (800) 526-6367, was previously approved for prevention of kidney transplant rejection in adults and as a prophylactic for heart transplant patients.
Pharmacia Corp., Peapack, N.J. (800) 253-8600, has received FDA approval to market Detrol LA (tolterodine tartrate extended-release capsules), a once-daily therapy indicated for treatment of the symptoms of overactive bladder. The capsules offer a new formulation of Pharmacia's currently marketed Detrol tablets, also approved for treatment of overactive bladder, a condition affecting some 17 million Americans.
Humalog Mix 75/25 (75% insulin lispro protamine suspension, 25% insulin lispro injection [rDNA origin]), is now available in 10-ml vials. The new vial form, from Eli Lilly & Co., Indianapolis, (317) 276-2000, makes the insulin mixture available to diabetes patients who prefer to use traditional vial and syringe therapy. The medication was previously available only in Lilly's prefilled insulin pen, which will still be available.
Odyssey Pharmaceuticals, East Hanover, N.J., (877) 427-9068, is introducing its newest branded phar-maceutical product, Antabuse 250-mg tablets (disulfiram). Disulfiram, indicated as an aid in the management of selected chronic alcohol patients who wish to remain in a state of enforced sobriety, should be used along with a program of motivation and support therapy, according to the company. The drug has been known and dispensed for 30 years, but the trademark and NDA have recently been purchased from American Home Products.
Unimed Pharmaceuticals, Deerfield, Ill., is now the sole marketer of Marinol CIII (dronabinol) capsules. This synthetic form of tetrahydrocannabinol is indicated for treatment of cancer chemotherapy-induced nausea and vomiting that is unresponsive to conventional medications and for appetite loss or anorexia associated with weight loss in AIDS patients. The product was formerly comarketed by Roxane Laboratories and Unimed. For more information, call (312) 297-7565.
Santen Inc., Napa, Calif., (707) 254-3648, has begun marketing Betimol (timolol ophthalmic solution) 0.25% and 0.5%. The product, indicated for treatment of elevated intraocular pressure, had been licensed to CIBA Vision (now Novartis Ophthalmics).
Novartis Pharmaceuticals Corp., East Hanover, N.J., (973) 781-8300, has acquired Famvir (famciclovir) and Denavir (penciclovir) from SmithKline Beecham as a result of antitrust considerations related to SmithKline's merger with Glaxo Wellcome. Famvir is indicated for the suppression and treatment of recurrent genital herpes and treatment of herpes zoster (shingles); Denavir is a topical cream indicated for treatment of recurrent cold sores on the lips and face of otherwise healthy adults.
Taro Pharmaceutical Industries Ltd., Hawthorne, N.Y., (914) 345-9001, has gained ANDA approval for carbamazepine oral suspension, 100 mg/5 ml (carbamazepine suspension), an anticonvulsant used in the treatment of epilepsy and other seizure disorders. This approval provides a generic alternative to Novartis' Tegretol Suspension. The oral suspension dosage form is used primarily in the pediatric setting.
An abbreviated new drug application (ANDA) has been approved for cefaclor extended-release tablets, USP, 500 mg. Cefaclor is indicated for the treatment of patients with mild to moderate infections. The product is made by IVAX Corp., Miami, (305) 575-6043, and is said to be equivalent to Ceclor CD tablets, from Eli Lilly & Co.
FDA approval has been given to Eon Labs Manufacturing, Laurelton, N.Y., (718) 276-8600, to market fluvoxamine maleate tablets, 25 mg, 50 mg, and 100 mg. The approval provides a generic alternative to Luvox, from Solvay Pharmaceuticals. The product is indicated for obsessive compulsive disorder.
A new FDA approval for fluvoxamine maleate tablets has also been granted to F. H. Faulding, Elizabeth, N.J., (908) 527-9100. The product will be marketed under the Purepac brand name.
Cyclosporine soft gelatin capsules, USP (Modified), 25-mg and 100-mg, has received FDA approval. The immunosuppressant, from Sidmak Laboratories, East Hanover, N.J., (973) 386-5566, is AB rated and bioequivalent to Novartis' Neoral Soft Gelatin Capsules. The drug is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
Danbury Pharmacal, Danbury, Conn., the drug-manufacturing unit of Schein Pharmaceutical, has tentative approval to market generic ciprofloxacin tablets, 100 mg, 250 mg, 500 mg, and 750 mg. This is a broad-spectrum antibiotic most effective against anaerobic gram-negative organisms. Call (203) 744-7200 for more information.
Watson Pharmaceuticals, Corona, Calif., (909) 270-1400, has gained approval for oxycodone and acetaminophen tablets, USP, 7.5 mg/500 mg and 10 mg/650 mg. The approval offers a generic alternative to Endo Pharmaceuticals' Percocet tablets, used for treatment of moderate to severe pain.
Natrol Inc., Chatsworth, Calif., (818) 739-6000, has introduced Natrol Dry Mouth Relief. This dietary supplement utilizes a patented pharmaceutical grade of anhydrous crystalline maltose, which is said to relieve the chronic dry mouth of people suffering from xerotomia or the side effects of prescription drugs.
For people who like to spice up their lives with hot foods but must suffer the consequent heartburn, there is now Pepcid Complete, from Johnson & Johnson/Merck (215) 233-7700. This two-in-one remedy provides 800 mg calcium carbonate and 165 mg magnesium hydroxide to neutralize acid, plus 10 mg famotidine to prevent the production of excess acid.
Del Pharmaceuticals, Farmingdale, N.Y., (516) 844-2020, is repositioning its ArthriCare line of pain-relief products to target the primary sufferers and treaters of arthritis pain. ArthriCare For Women, with its quick-drying formula, employs a penetrating pain blocker the company claims is not usually found in topical rubs. The cream goes on dry like a powder and is absorbed into the skin, leaving no residue. With vitamins A and E, it is formulated to nourish, moisturize, and pamper the skin as it provides pain relief.
Great Neck, N.Y.-based ND Labs, (516) 504-0292, is introducing SoyPro Protein Powder Supplement in single-serving units. This nutritional supplement, said to be easily digestible, combines a 100% natural vegetable protein, calcium, and isoflavones. It provides 6.5 gm of protein and 225 mg of calcium per serving.
Lifestream Technologies, Post Falls, Idaho, (208) 457-9409, has introduced its Lifestream cholesterol monitor. The device employs the Microsoft Smart Card operating system that allows customers to securely store test results and share them with their health-care professionals. The monitor is expected to be selling in drugstores shortly.
Anyone with gripping difficulties will appreciate the Ableware Ring Writer Clip from Maddak Inc., Pequannock, N.J., (973) 628-7600. A large ring slips over a finger or thumb, and a smaller ring fits over the writing implement to supply a measure of control. Suggested retail price for a bag of three to fit different-sized fingers is $3.45.
FDA approval for marketing has been give to the Glucometer, a blood glucose monitoring system from Cyber-Care, Atlanta, (770) 352-9540. The monitor will be integrated with the company's Electronic HouseCall System products and will enable physicians to monitor diabetic patients remotely.
Ralph Thurlow. New Product Newswire.