Protonix (pantoprazole sodium) delayed-release tablets have been cleared by the FDA for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. According to the manufacturer, Wyeth Pharmaceuticals, Collegeville, Pa., (800) 666-7248, this new approval makes Protonix the first proton pump inhibitor with both IV and oral formulations to treat this painful and potentially fatal condition.
IVAX Corp. has garnered FDA approval for the use of QVAR (beclomethasone dipropionate HFA) to treat asthma in children aged five through 11 years. The corticosteroid, suspended in a non-ozone-depleting hydrofluoroalkane propellant, is delivered in particles small enough to easily reach the small airways of the lung. QVAR is currently marketed for the treatment of asthma in adults and older children by company subsidiary IVAX Laboratories, Miami, (305) 575-6215.
Retin-A Micro 0.04% (tretinoin gel), a lower-dose formulation of Retin-A Micro, has gained FDA approval as a topical treatment for acne. It will be marketed by Ortho Neutrogena, a subsidiary of Johnson & Johnson, New Brunswick, N.J., through an agreement with A. P. Pharma, with whose Microsponge technology the product is formulated. For further information, call (800) 217-1136.
King Pharmaceuticals, Bristol, Tenn., (423) 989-2000, and Ortho-McNeil Pharmaceutical have signed an agreement whereby King will acquire Ortho-Prefest (estradiol/norgestimate) tablets in the United States. The drug is indicated as hormone replacement therapy to treat the vasomotor symptoms of menopause as well as vulvar and vaginal atrophy, and to prevent osteoporosis. The drug will retain its current name until the FDA approves a name change to Prefest.
Biovail Corp., Toronto, (416) 285-6000, in an agreement with Merck & Co., has acquired U.S. rights for Vasotec (enalapril) and Vaseretic (enalapril with hydrochlorothiazide) as well as for the fixed-dose combination of enalapril in combination with diltiazem malate. Vasotec, an ACE inhibitor, and Vaseretic, a fixed-dose combination of Vasotec and the diuretic hydrochlorothiazide, are first-line agents for the treatment of hypertension and congestive heart failure.
SpectRx, Norcross, Ga., (770) 242-8723, has FDA clearance for the use of its SimpleChoice easy disposable infusion set with the Medtronic MiniMed Paradigm insulin pump, from Medtronic Inc., Minneapolis, (763) 505-2692. According to the company, this is the only alternative insulin pump disposable infusion set to be approved for use with all major makes and brands of insulin pumps. Insulin infusion sets, which are changed approximately every three days, are attached to external pumps to provide a steady stream of insulin for people with diabetes.
Abbott Laboratories, Abbott Park, Ill., (800) 222-6883, and NaPro BioTherapeutics Inc., Boulder, Colo., (303) 516-8500, have, through a cross-license agreement with Bristol-Myers Squibb, an exclusive collaboration agreement to develop and market paclitaxel injection in the United States. The product is equivalent to BMS' Taxol (paclitaxel) Injection, a taxane antineoplastic product for treatment of metastatic carcinoma of the ovary after failure of prior therapy and for treatment of breast cancer after failure of combination chemotherapy. The drug will be available in 30-mg, 100-mg, and 300-mg multidose vials.
A new sodium levothyroxine dosage form, Levo-T, from MOVA Pharmaceutical Corp., Caguas, P.R., (800) 468-5201, has been approved for the U.S. market using PROSOLV technology from Patterson, N.Y.-based Penwest Pharmaceuticals, (800) 431-2457. Levo-T is indicated for both the treatment of hypothyroidism and the suppression of thyroid-stimulating hormone. Use of the PROSOLV technology, according to Penwest, enables MOVA to provide tablets with the content uniformity essential to ensuring proper efficacy of the drug.
The FDA has approved cyclosporine capsules, USP, from Apotex Corp., Weston, Fla., (800) 706-5575. The company claims it is the only generic drug manufacturer to gain approval for this equivalent to Novartis' Sandimmune. The capsules are available in both 25-mg and 100-mg strengths and are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
A new lotion from Fougera, Melville, N.Y., (800) 645-9833, has received FDA approval. Clindamycin phosphate lotion 1% (clindamycin phosphate topical suspension USP, 1%), available in 60-ml bottles, provides a generic alternative to Pharmacia's Cleocin T Lotion, indicated for topical treatment of acne vulgaris.
Par Pharmaceutical, a subsidiary of Pharmaceutical Resources, Spring Valley, N.Y., (845) 425-7100, has marketing approval for flecainide acetate. The antiarrhythmic medication provides a generic alternative to 3M's Tambocor.
Sicor Inc., Irvine, Calif., (949) 455-4879, has received two separate ANDA approvals: for idarubicin hydrochloride for injection, a lyophilized powder for reconstitution, and idarubicin hydrochloride injection, a ready-to-use liquid formulation. The branded product, Pharmacia's Idamycin, is indicated for the treatment of acute myeloid leukemia in adults.
Generic gabapentin is now approved for Miami-based IVAX Corp., (305) 575-6000, and Purepac Pharmaceutical, Elizabeth, N.J., (908) 527-9100. Gabapentin, an anticonvulsant indicated for epileptic seizures, provides an alternative to the branded drug Neurontin, from Pfizer Inc. The product will be available in 100-, 300-, and 400-mg doses.
For supplemental nutrition, Baxter International, Deerfield, Ill., (847) 948-2000, offers a line of noncarbonated bottled waters, in a variety of flavors, for men's and women's health and the health of the heart. Pulse contains soy isoflavones; calcium; magnesium; folic acid; vitamins D, B6, and B12; and sucralose, a sugar substitute. A 16-oz. bottle contains about 40 calories.
From Bayer Consumer Care, Morristown, N.J., (800) 343-2240, comes new Bactine pain relief with antibiotic properties: Bactine Pain Relieving Protective Antibiotic, Pain Relieving Cleansing Spray, and Pain Relieving Cleansing Wipes.
For overweight children, there is a new dietary supplement from Klein-Becker, Provo, Utah. PediaLean is a fiber-rich, plant-derived product that can help children lose weight naturally in conjunction with exercise and a healthy diet. For ordering information, call (800) 572-6502.
Medifast Plus for Diabetics, from Medifast Inc., Owings Mills, Md., (410) 581-8042, is a low-glycemic product that has received a seal of approval from the Glycemic Research Institute. The product is formulated especially for people with insulin-related disorders, as well as for athletes, to help keep their blood glucose and insulin levels in check.
Available from Maddak Inc., Pequannock, N.J., (973) 628-7600, are two new products. One is a plastic-coated walker basket that attaches to a walker with Velcro fasteners. It provides one large compartment; a coin or medication holder; and a compartment for a glass, can, or cup. A Bath+Safe lock-on elevated toilet seat comes with arms to add stability and patient assistance. It supports up to 300 pounds and fits most standard toilet seats.
Alistagen Corp., New York City, (212) 996-3216, offers a productfor application to walls, floors, and other hard surfacesthat it says will help control the spread of infectious disease. Caliwel is a nontoxic, natural mineral-based antimicrobial surface coating that has received marketing clearance from the EPA. The company claims that the product is 99.9% effective against more than 20 microbes that cause such diseases as asthma, allergies, staph infection, flu, polio, hepatitis, cholera, and Legionnaires' disease. The coating kills most microbes within five to 15 minutes of application and remains active for up to six years.
Nancy Jillard. New Product Newswire. Drug Topics 2002;11:71.