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Rxs, OTCs, and others
Novartis, based in East Hanover, N.J., (800) 496-6382, has been granted FDA approval for its new-generation intravenous bisphosphonate, Zometa (zoledronic acid for injection) for the treatment of hyper-calcemia of malignancy (HCM). HCM is a life-threatening metabolic complication associated with cancer characterized by elevated serum calcium levels. According to the company, Zometa is more efficacious than the current treatment standard, its own Aredia (pamidronate sodium for injection), and offers the convenience of a shorter infusion time, as compared with two to 24 hours for Aredia. Patients must be adequately hydrated prior to administration of the drug and have their renal function closely monitored. The recommended dose of 4 mg is given as a single-dose intravenous infusion over no less than 15 minutes.
Genotropin Lyophilized Powder (somatropin [rDNA origin] for injection), from Pharmacia Corp., (800) 821-7000, has been granted FDA approval for a new indication: the long-term treatment of growth failure in children born small for gestational age (SGA) who do not achieve catch-up growth by the age of two. The drug was also granted orphan drug status for this newest indication. Since 1995, Genotropin has been approved for the long-term treatment of growth failure in children due to growth hormone deficiency (GHD), and since 1997 as replacement therapy in adults with GHD. In 2000, the drug was granted orphan drug status for children suffering from growth failure due to Prader-Willi syndrome.
Questcor Pharmaceuticals, Union City, Calif., (510) 400-0700, has acquired the worldwide rights to market H.P. ACTHar Gel (repository corticotropin injection), from Aventis Pharmaceuticals. As part of a special program administered by the National Organization for Rare Disorders (NORD), this highly purified corticotropin product has been used to treat children with a potentially fatal seizure complex called West syndrome, also known as infantile spasms. In the past few years, there was limited availability of H.P. ACTHar Gel, owing to limited production. However, now back in full production, the product will no longer be limited to distribution via NORD's special access program. First shipments of H.P. ACTHar Gel are expected to reach wholesalers sometime in September.
In early August, IVAX Corp., Miami, (305) 575-6000, received FDA approval for its Abbreviated New Drug Application (ANDA) for isosorbide mononitrate extended-release tablets in 30-mg and 120-mg strengths. Isosorbide mononitrate is indicated for treatment of angina pectoris due to coronary artery disease. It provides a generic alternative to Schering Corp.'s Imdur tablets. IVAX will sell the product through IVAX Pharmaceuticals, its wholly owned subsidiary. IVAX had previously received FDA approval for its Isosorbide Mononitrate extended-release 60-mg tablets.
Bedford Laboratories, Bedford, Ohio, (440) 232-3320, a division of Ben Venue Laboratories, has obtained FDA approval for dacarbazine for injection USP. The new approval provides a generic equivalent to Bayer Corp.'s DTIC-Dome, an antitumor product indicated for the treatment of metastatic malignant melanoma. Dacarbazine for Injection USP is also indicated as second-line therapy for Hodgkin's disease when used in combination with other effective agents and will be supplied in 200-mg vials.
Bedford Laboratories has also received approval to market paclitaxel injection, a generic equivalent to Bristol-Myers Squibb's Taxol Injection. This antitumor product is indicated for the treatment of metastatic carcinoma of the ovary after the failure of first-line or subsequent chemotherapy. Paclitaxel Injection is also indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Bedford Laboratories will offer Paclitaxel Injection in 30-mg, 100-mg, and 300-mg multiple-dose vials.
UDL Laboratories, Rockford, Ill., (800) 848-0462, a subsidiary of Mylan Laboratories, also has approval to distribute paclitaxel injection. The company will make the product available in 30-mg, 100-mg, and 300-mg multiple-dose vials.
Paclitaxel from UDL is indicated as subsequent therapy for the advanced carcinoma of the ovary as well as for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. According to the product's labeling, prior therapy should have included an anthracycline unless clinically contraindicated.
Four new dietary supplements in the Osteo Bi-Flex line of joint-health products are now available from Rexall Sundown, Boca Raton, Fla., (888) 848-2435. Osteo Bi-Flex Soft Fruit Chews provide a daily dose of 1500 mg of glucosamine and 1200 mg of chondroitin in three of the honey lemon- or cherry-flavored chews. Osteo Bi-Flex Fast-Acting Formula combines glucosamine and chondroitin with willow bark, a natural ingredient that works to promote joint comfort. Osteo Bi-Flex Plus MSM is a timed-release formula that provides 1000 mg of methylsulfonylmethane, a source of dietary sulfur, per daily dose to enhance the benefits of glucosamine and chondroitin. Osteo Bi-Flex Performance is a formulation that combines glucosamine and chondroitin with a blend of complementary vitamins and minerals geared to providing active nutrition for joints and muscles.
A new product designed to help people with elevated cholesterol is now available from Twinlab, Hauppauge, N.Y. Cholesterol Success is the first dietary supplement to contain Reducol900 mg per servinga proprietary plant-based sterol/stanol blend. According to results from clinical tests, this formulation can help reduce cholesterol levels up to 24%, when combined with a healthy diet low in saturated fat and cholesterol, by blocking the absorption of cholesterol in the intestine. The suggested regimen is either two pills or one chewable wafer just before breakfast and dinner. For further information, contact the consumer affairs department at (800) 645-5626.
ARTHxDS Time Release Formula, containing 1500 mg glucosamine and 1200 mg chondroitin, is available to help relieve the symptoms of those suffering from stiffness or joint pain sometimes associated with osteoarthritis. As a two-caplet, once-daily dosage, it is formulated to help repair and maintain proper joint health in approximately eight weeks. According to Medtech Inc., Jackson, Wyo., (307) 733-1680, which purchased the product from Pecos Pharmaceuticals, the time-release formula dissolves slowly and extends the absorption period of the vital nutrients, allowing users to receive the necessary level of therapeutic benefit in a once-a-day administration. The dosage may be lowered after the desired results are achieved. ARTHxDS Time Release Formula is available in containers of 40 or 80 capsules.
New Millennium Health & Nutrition, Crystal Lake, Ill., (866) 362-6659, has introduced a new line of nutritional supplements called Doctor's Choice Colostrum. The first and only Kosher-certified Colostrum line, Doctor's Choice features New Zealand's Grade 1 low- heat-processed Colostrum, called NZGold, obtained from the fluid secreted by a cow's mammary glands after birth and pre-milk. The product line, which contains a range of immune factors, vitamins, minerals, and amino acids, is available in chewable tablets, vanilla-flavored capsules, an unflavored powder, and two vanilla-flavored drink mixes called Immuno Boost and Immuno Boost Plus.
AlphaRx is pitching LipoLette AM and LipoLette PM supplement for weight control. The Richmond Hill, Ontario, firm claims the dietary supplement contains a natural plant extract that limits the action of lipases, the intestinal tract digestive enzymes responsible for the body's absorption of fat. AlphaRx is also promoting Oralife, an all-natural antimicrobial mouth rinse containing grapefruit seed extract (GSE), which kills the bacteria in plaque. To contact the company, call (905) 762-0745.
Women with varicose veins can now try a new nutraceutical called the Complete La Femme Vein Support Formula. Produced by Baywood International, Scottsdale, Ariz., the product contains diosmin and hesperidin, which are found in plants and purport to maintain healthy veins and promote venous flow. Since the product is not limited to use by women, the company is also planning to offer the product under its Purechoice line. For information, call (888) 350-0799.
Cooke Pharma, Silver Spring, Md., (301) 608-9292, has introduced a reformulated HeartBar, improving on the original with enhanced taste and a 25% reduction in calories. To be used under the supervision of a physician, the HeartBar is a medical food that improves coronary and peripheral blood flow, increases treadmill exercise performance, and reduces episodes of angina in individuals with cardiovascular disease. In addition to the HeartBar, Cooke Pharma also released HeartBar Orange Drink, which offers the same cardiovascular benefit as one HeartBar.
Available from Maddak Inc., Pequannock, N.J., (973) 628-7600, is the Ableware Deluxe Flexible Sock and Stocking Aid, designed to assist the disabled in donning socks and stockings. The device is equipped with three fingers and two long loops to help those with back problems or limited hand function. Suggested retail price for the aid is $12.85.
Barbara Klink. New Product Newswire. Drug Topics Sep. 3, 2001;145:65.