New products for first issue 1/00
Ridgefield, Conn.-based Boehringer Ingelheim, (203) 798-9988, has received approval for Micardis HCT Tablets (telmisartan/hydrochlorothiazide), a once-daily treatment for hypertension. The product, for patients unable to control their blood pressure with a single agent and who require a more intense blood pressure-lowering effect, combines the angiotensin II receptor blocker Micardis 40 mg and 80 mg with a 12.5-mg fixed dose of hydrochlorothiazide.
FDA approval has been granted to SmithKline Beecham, Philadelphia, (215) 751-4000, to market Argatroban Injection (argatroban) in the United States. The agent is a synthetic direct thrombin inhibitor for the prophylaxis or treatment of thrombosis associated with heparin-induced thrombocytopenia. Under an agreement with the developer of the drug, Houston-based Texas Biotechnology Corp. (TBC), SB has the rights to market and further codevelop Argatroban in the United States. The drug was already in use outside the U.S. Further information is available from TBC, (713) 796-8822.
Tamiflu (oseltamivir phosphate) has been approved by the FDA for the prevention of influenza A and B. According to its developers, Hoffmann-La Roche, Nutley, N.J., (973) 235-5000, and Gilead Sciences, Foster City, Calif., it is the only approved option for both flu treatment and prevention. For treatment, dosing is 75 mg twice daily for five days; for prevention, 75 mg once daily for seven days for postexposure; and once daily for 42 days for either seasonal or outbreak protection. Tamiflu was first approved in October 1999 as a treatment for both types of flu in adults.
Wallace Laboratories, Cranbury, N.J., (609) 655-6000, has garnered FDA approval for Astelin Nasal Spray (azelastine HCl), 137 mcg, for the treatment of nonallergic vasomotor rhinitis in patients age 12 years and older. The antihistamine was already approved for treatment of seasonal allergic rhinitis in patients five years of age and older.
AstraZeneca Pharmaceuticals, Westborough, Mass., (508) 366-1100, has received FDA approval for an increase in dosage and du-ration for its anesthetic Naropin (ropivacaine HCl). The dosage was increased from 5.0 mg/ml to 7.5 mg/ml for major nerve blocks; the infusion duration was increased from 24 hours to 72 hours for postoperative pain management. Naropin was already indicated as a local or regional anesthesia for surgery, management of postoperative pain, and obstetric procedures.
Renova Cream (tretinoin cream) 0.02% is now available by prescription. The new formulation is said to be effective in reducing fine facial wrinkles when used as part of a total skin care and sun-protection program. The product is marketed by Ortho Dermatological, Skillman, N.J., (908) 904-3365.
Odyssey Pharmaceuticals, East Hanover, N.J., (877) 427-9068, in a licensing agreement with Sidmak, is introducing Vivactil (protriptyline HCl, USP) Tablets in new shapes and colors. The product, indicated for treatment of mental depression, is available in a 10-mg tablet strength as well as the reintroduced 5-mg tablet.
Alpharma Inc., Fort Lee, N.J., (201) 947-7774, has been granted approval of its Minoxidil Topical Solution USP 5% for Men, providing an alternative to Pharmacia & Upjohn's Rogaine Extra Strength 5% for Men. The product is indicated for treatment of gradually thinning hair or gradual hair loss on the top of the scalp.
FDA approval was given to Sidmak Laboratories, East Hanover, N.J., (973) 386-5566, for ketorolac tromethamine 10-mg tablets. This nonsteroidal anti-inflammatory drug or analgesic agent is indicated for short-term use in moderately severe acute pain. It provides a generic alternative to Roche Laboratories' Toradol tablets and is available in bottles of 100 and 1,000 tablets.
IMPAX Laboratories, Hayward, Calif., (215) 289-2220, has received approval for sotalol hydrochloride tablets, indicated for the treatment of documented ventricular arrhythmias. The product offers a generic version of Berlex Laboratories' Betapace.
Bedford Laboratories, Bedford, Ohio, (440) 232-3320, has received marketing approval for propranolol hydrochloride injection USP. The product is claimed to be equivalent to Wyeth-Ayerst's Inderal, a synthetic beta-adrenergic receptor blocking agent indicated for cardiac arrhythmias. The generic product will be packaged in 1-ml single-dose vials as an alternative to Wyeth's ampules.
Eon Labs, Laurelton, N.Y., (800) 526-0225, has introduced bisoprolol fumarate in 5- and 10-mg tablets for treatment of hypertension. The manufacturer claims the product is the first generic to be proven bioequivalent to Lederle's Zebeta.
Tentative approval was issued to Mylan Laboratories, Morgantown, W.Va., (800) 826-9526, for its generic version of Eli Lilly's Axid (nizatidine) capsules, indicated for treatment of gastroesophageal reflux disease, duodenal ulcers, and active benign gastric ulcers. Lilly's patent on Axid will expire in April 2002.
TEVA Pharmaceuticals USA, North Wales, Pa., (888) TEVA USA, is making available its doxazosin mesylate tablets in 1-, 2-, 4-, and 8-mg strengths. The company claims the product is bioequivalent to Pfizer's Cardura tablets, indicated for benign prostatic hyperplasia and hypertension.
Compound W One Step Wart Remover for Kids is being offered in newly designed bright colors, sporting the cartoon character Garfield on the salicyclic acid-impregnated one-step pad. The product, from Medtech Inc., Jackson, Wyo., retails for approximately $9.73. For further information, call (914) 241-0086.
Alcon Laboratories, Fort Worth, (817) 293-0450, reports that the FDA has cleared Opti-Free Express Multi-Purpose Disinfecting Solution for use without the rubbing step for all soft-lens wearing schedules. Alcon earlier launched a similar product for lenses worn 30 days, but the new product, said the company, extends no-rub clearance to all soft lenses regardless of wearing schedule.
ErgoPharm, Seymour, Ill., (949) 566-9841, is introducing sports and fitness health supplementsAndro Stack, Androdiol/NorAn-dro diol Stack, Nordiol/Stack, and Androdiol Heatunder the firm's ErgoPharm Substrate Series. The products will utilize the proprietary dispersion technology of Nutraceutix Inc., which increases solubility and bioavailability of insoluble nutrients to enhance utilization by the body.
DexGen Pharmaceuticals, Manasquan, N.J., (877) DEXGEN1, is offering DexAlone, a single-agent formulation of dextromethorphan hydrobromide, in a 30-mg liquid gelcap. The formulation, offering a nonliquid dosage form for those unable to take syrups, contains no alcohol, phenylpropanolamine, antihistamine, or lactor. The product comes in boxes of 30 cough caps.
Pediasure is now available in improved chocolate, vanilla, strawberry, and banana cream flavors. The Ross Products Division of Abbott Laboratories, Abbott Park, Ill., (614) 624-3948, offers the nutritionally balanced drink for children from one to 10 years of age who may not be getting enough dietary nutrients.
The Omron MC-600 3-Way Instant Thermometer, delivering an oral, rectal, or underarm reading in four to six seconds, is new from Omron Healthcare, Vernon Hills, Ill., (800) 634-4350. It determines temperature (in either Fahrenheit or Centigrade) with two sensors that measure heat flow from blood vessels to the skin, eliminating the risk of glass breakage or mercury poisoning. With 9-volt battery included, it carries a suggested retail price of $49.99.
From Maddak Inc., Pequannock, N.J., (973) 628-7600, comes the Maddacare Footrest, ergonomically designed to reduce the risk of carpal tunnel syndrome. With a foot elevation of four inches on one side, six inches on the other, it weighs 4.5 lb. and carries a suggested retail price of $39.75.
Medicine-On-Time Plus, from Medicine-On-Time, Owings Mills, Md., (800) 722-8824, offers a fully integrated wristwatch that digitally stores patient record, tracks medical symptoms, and audibly reminds patients to take their medications. The data in the watch enable a pharmacist to custom-sort and package a patient's prescription medication into a series of clear dosage cups arranged on a color-coded calendar card, hermetically sealed and clearly labeled with the patient's name, the contents, and the precise dosing time. The watch is expected to retail for less that $100; it can also be obtained for a small monthly fee as part of the company's service.
United Pacific, Columbia, S.C., (803) 735-0034, has expanded its line of knee pain relief products with the triple-layer Thermoskin Knee Wrap Stabilizer. The center layer is made of Trioxon, a material that allows skin to ventilate by wicking without closing off the pores of the skin as it raises skin temperature two to three degrees. Adjustable with Velcro tabs, it supports the knee in patients suffering with chronic pain.
Lightwave Comfort 70 support hose has been introduced by Medi-sana USA, Charlotte, N.C., (704) 847-1338. Its 70-denier strength helps to increase blood circulation in women's legs with a massaging action to energize tired, aching muscles.
Lifestream Technologies, Post Falls, Idaho, (208) 457-9409, is rolling out a hand-held personal cholesterol monitor. A built-in smart card reader allows patients to store the test results in private medical files on-line for sharing with their doctor and pharmacist. The device is said to give accurate results in three minutes.
Ralph Thurlow. NEW PRODUCT NEWSWIRE. Drug Topics 2001;1:69.