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New producsts for March 19
AstraZeneca, Wilmington, Del., (800) 942-0424, has received FDA approval for an orally disintegrating tablet form of Zomig (zolmitriptan), 2.5 mg, for the treatment of migraine with and without aura. This new treatment option, which will be known as Zomig-ZMT in the United States, can be taken without liquids, thus making treatment more convenient. The tablet has already been launched in 15 other countries, where it is predominantly marketed as Zomig Rapimelt.
Upsher-Smith Laboratories, Minneapolis, (800) 654-2299, has expanded its Folgard line with a prescription-strength dietary supplement and folic acid product. Folgard RX 2.2 (folic acid, vitamin B6, vitamin B12 combination) is available in 100-count bottles.
The FDA has granted Eli Lilly & Co., Indianapolis, (317) 276-2000, approval for Prozac Weekly (fluoxetine hydrochloride) for use in the continuation phase of major, long-term depressive disorder. This delayed-release formulation of Lilly's antidepressant Prozac is indicat-}ed for patients whose depressive symptoms have stabilized and who require continuing treatment to prevent a relapse. The enteric-coated capsules contain 90 mg of fluoxetine hydrochloride equivalent to 90 mg of fluoxetine. The enteric coating delays the drug's release into the bloodstream, thereby taking advantage of the protective effects of fluoxetine's naturally long half-life. The product will be available in a wallet-size blister package containing a four-week supply (four capsules).
Odyssey Pharmaceuticals, East Hanover, N.J., (877) 427-9068, a wholly owned subsidiary of Sidmak Laboratories, has launched Urecholine (bethanechol chloride) in three additional dosage strengths: 5-mg, 10- mg, and 50-mg scored tablets. The drug was previously available only in 25-mg tablets. Urecholine is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
A new aqueous form of acyclovir sodium injection in 500 mg/10 ml and 1 g/20 ml plastic vials, as well as a 500 mg/10 ml vial in powder form, is now available from American Pharmaceutical Partners, Schaumburg, Ill., (888) 391-6300. According to the company, the new aqueous solution helps to ensure correct dosing and saves time and labor for health-care professionals. It is said to remain shelf-stable for months prior to opening. In injectable form, acyclovir is indicated for treatment of initial and recurrent mucosal and cutaneous HSV-1 and HSV-2 and varicella-zoster (shingles) infection in immunocompromised patients, herpes simplex encephalitis, and severe initial clinical episodes of genital herpes in patients who are not immunocompromised. The new generic provides an alternative to Zovirax (GlaxoSmithKline).
Eon Labs Manufacturing, Laurelton, N.Y., (800) 526-0225, has FDA approval for oxaprozin 600-mg tablets, providing a generic alternative to Searle's Daypro. The tablets are available in 100-, 500-, and 1,000-count bottles. The nonsteroidal anti-inflammatory (NSAID) is indicated for acute and long-term use in the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Pharmaceutical Resources, Spring Valley, N.Y., (845) 425-7100, has received tentative approval from the FDA to market fluoxetine in 10-mg and 20-mg capsules. The product, which provides a generic alternative to Prozac, from Eli Lilly & Co., is a selective serotonin reuptake inhibitor indicated for the treatment of depression.
Pharmaceutical Resources has also been granted FDA approval to market oxaprozin 600-mg tablets. Its wholly owned subsidiary, Par Pharmaceutical, will distribute the drug. The product was developed through a strategic alliance with Merck KgaA.
A new menopause pro-duct is now available from PhytoPharmica, Green Bay, Wis., (800) 553-2370. AM/ PM Menopause Formula is dedicated to the broad spectrum of menopausal symptoms, such as hot flashes, fatigue, mood variations, sleeplessness, and inability to relax. The product contains two color-coated tabletsone for daytime use, the other for evening use. The AM formula combines panax ginseng and green tea to support the body's energy production. The PM formula contains kava, valerian, and hops to promote relaxation and sleep. Black cohosh, common to both, is a traditional herb for menopause symptom relief ... PhytoPharmica is also introducing PMS Formula with Indolplex, a dietary supplement with six nutrients for relief of premenstrual symptoms. According to the company, the key component is Indolplex, a patented proprietary biodelivery system that promotes a favorable ratio of a woman's "good" to "bad" estrogen metabolites, thus supporting hormonal health.
A new blood glucose testing system that delivers blood sugar readings in only five seconds is now available from LifeScan, Milpitas, Calif., (408) 263-9789, a Johnson & Johnson company. Recently cleared by the FDA, the One Touch Ultra Blood Glucose Monitoring System offers diabetes patients a less painful alternative to the traditional fingerstick. The new system requires only a tiny drop of blood (1 microliter), allowing most people to test on the arm, which has fewer nerve endings than the fingertips. The system also eliminates waiting by providing clinically accurate results in just a few seconds. Its broad operating temperature range (43° to 111° F) gives patients the freedom to test their blood glucose outdoors in a wider range of hot and cold conditions. Among its other features, the One Touch Ultra System boasts a 150-test memory with time and date; 14- and 30-day test averaging; no cleaning; and the option to download test data to a personal computer using LifeScan's In Touch Diabetes Management Software, version 1.32, available separately from LifeScan.
Barbara Klink. New Product Newswire. Drug Topics 2001;6:50.