NEW PRODUCT NEWSWIRE

Rx

NEW DRUGS

Women First HealthCare, a specialty pharmaceutical company in San Diego, (800) 861-4002, is introducing an FDA-approved combination Schedule III drug to treat moderate to moderately severe pain. Each Synalgos DC painpak provides 12 capsules, each of which contains dihydrocodeine bitartrate, aspirin, and caffeine.

NEW INDICATIONS

Kytril Injection (granisetron hydrochloride), an antiemetic from Roche Pharmaceuticals, Nutley, N.J., (800) 526-6367, has been cleared for both prevention and treatment of postoperative nausea and vomiting. Kytril, a selective blocking agent of the serotonin 5-HT₃ receptor, was first approved in 1999 for radiation therapy-induced nausea and vomiting.

Ritalin LA extended-release capsules, a once-daily formulation of Ritalin (methylphenidate hydrochloride), has been approved by the FDA. Ritalin, a product of Novartis Pharmaceuticals, East Hanover, N.J., (973) 781-8300, is prescribed for the treatment of attention deficit hyperactivity disorder.

NEW FORMULATION

A new low-dose formulation of the contraceptive Ortho Tri-Cyclen has been approved by the FDA. Ortho Tri-Cyclen LO (norgestimate/ethinyl estradiol), a product of Ortho-McNeil Pharmaceutical, Raritan, N.J., (800) 682-6532, is indicated for the prevention of pregnancy.

NEW GENERICS

The FDA has given the nod to Watson Pharmaceuticals, Corona, Calif., (909) 493-5611, and to TEVA USA, North Wales, Pa., (888) TEVA-USA, for their generic versions of Adalat CC (once-daily nifedipine, Bayer AG). Nifedipine Extended-Release Tablets, 90 mg, a calcium-channel blocker, are indicated for the treatment of hypertension, either alone or in combination with other antihypertensive agents. Approval was also given to TEVA's marketing partner, Biovail Corp., Toronto, for the same drug, which will be marketed through TEVA USA.

Caraco Pharmaceutical Laboratories, Detroit, (313) 871-8400, has FDA approval to market meperidine hydrochloride, used in the treatment of severe pain. Meperidine, a narcotic analgesic, offers an alternative to Demerol, from Sanofi-Synthelabo.

Lannett Co., Philadelphia, (215) 333-9000, is now marketing digoxin tablets in 0.125- and 0.25-mg strengths. This generic version of GlaxoSmithKline's Lanoxin, a cardiac glycoside, is indicated for mild to moderate heart failure.

Sicor Inc., Irvine, Calif., (949) 844-2020, has received approval for promethazine hydrochloride injection, USP. The product is indicated for treatment of nausea and vomiting associated with certain types of anesthesia and surgery, as an adjunct to analgesics for the control of postoperative pain, as a mild sedative, and for treatment of some types of allergic reactions. This approval offers a generic alternative to Wyeth's Phenergan.

Purepac Pharmaceutical, Elizabeth, N.J., (908) 527-9100, has received clearance to manufacture and market gabapentin in 600- and 800-mg tablet strengths. Purepac, a subsidiary of Alpharma Inc., received approvable status for 100-, 300-, and 400-mg strengths earlier in the year. Gabapentin is indicated for treatment of partial seizures of epilepsy.

Andrx Corp., Fort Lauderdale, (800) 621-7143, holds two tentative approvals from the FDA. Loratadine and pseudoephedrine sulfate, USP extended-release tablets provide a generic alternative to Schering-Plough's Claritin-D 24 Hour. The antihistamine/decongestant combination is used to provide relief of symptoms of seasonal allergic rhinitis. Bioequivalent to AstraZeneca's Nolvadex are tamoxifen citrate tablets, USP, in 10-mg and 200-mg strengths. The nonsteroidal antiestrogen is used in the treatment of breast cancer ... Andrx has also gained provisional approval for its generic version of Bristol-Myers Squibb's Glucophage XR. Metformin extended-release tablets, an oral antihyperglycemic drug, are used in the management of Type 2 diabetes.

The FDA has tentatively approved alendronate sodium tablets, USP, 35 mg and 70 mg, from Barr Laboratories, Pomona, N.Y., (800) BARR LAB. The bisphosphonate, a generic alternative to Merck & Co.'s Fosamax tablets of the same strengths, is used in the treatment and prevention of osteoporosis in menopausal women and for increasing bone mass in men with osteoporosis. It is also indicated in the treatment of Paget's disease of the bone in men and women.

For the management of moderate to severe pain over an extended period of time, oxycodone extended-release tablets, in 10-, 20-, 40-, and 80-mg strengths, have been granted tentative approval. This opioid agonist and Schedule II controlled drug, from Endo Pharmaceu-ticals, Chadds Ford, Pa., (800) 462-3636, provides a generic alternative to Purdue Frederick's OxyCodone Extended-Release Tablets.

The FDA has given tentative approval to Impax Laboratories, Hayward, Calif., (510) 476-2000, for a generic version of Aventis' Rilutek tablets. Riluzole tablets, 50 mg, a member of the benzothiazole class of drugs, are indicated in the treatment of amyotrophic lateral sclerosis, extending survival and/or time to tracheostomy. Final approval is contingent on the expiration of orphan drug exclusivity later this year.

NEW ACQUISITIONS

Ovation Pharmaceuticals, Lincolnshire, Ill., (847) 955-9210, has acquired Tranxene (clorazepate dipotassium) and Desoxyn (methamphetamine hydrochloride) from Abbott Laboratories. Tranxene is a benzodiazepine used in the management of anxiety disorders, as adjunctive therapy for the partial seizures of epilepsy, and for symptomatic relief of acute alcohol withdrawal. Desoxyn is an amphetamine indicated for treatment of attention deficit hyperactivity disorder and exogenous obesity.

HOSPITAL PRODUCTS

Odyssey Pharmaceuticals, East Hanover, N.J., (877) 427-9068, has FDA permission to make Custodiol HTK solution available in the United States. The product is indicated for the perfusion and flushing of donor kidneys prior to or immediately following organ removal from the donor.

Aeroneb Pro, a nebulizer system from Aerogen Inc., Mountain View, Calif., (650) 864-7300, is designed to improve drug delivery during in-hospital respiratory therapy. Its delivery of fine-particle, low-speed aerosol helps maximize drug deposition in the lungs.

OTC

Available from Celltech Pharmaceuticals, Rochester, N.Y., (888) 963-3382, is a larger, 5-oz. size of its cough remedy Delsym. The liquid dextromethorphan formula is non-narcotic and offers 12-hour cough relief with only twice-daily dosing.

Blistex Inc., Oak Brook, Ill., (630) 571-2870, is introducing Blistex Clear Advance, a new lip balm for men that is said to last up to eight hours. It is formulated to glide on invisibly to prevent dry and chapped lips summer and winter and protect against cold sores. With its Parsol 1789 sunscreen, it also offers long-wavelength UVA protection against lip cancer.

Prosurgex, from Millennium Biotechnologies, Bernardsville, N.J., (908) 630-8700, is a high-protein, high-calorie nutritional meal replacement and supplement to be used as a nutritional adjunct to medical treatment for patients with AIDS, cancer, and chronic medical conditions. The powdered formulation is available in a single-use disposable container for mixing with water to provide a 400-calorie meal. It can be taken orally or delivered through an enteral feeding tube.

The FDA has now cleared the use of Bausch & Lomb's ReNu MultiPlus Multi-Purpose Solution No Rub Formula for all soft contact lenses, regardless of how often consumers replace their lenses. Bausch & Lomb is headquartered in Rochester, N.Y., at (800) 344-8815.

A highly bioavailable and superpotent form of (-)hydroxycitric acid (HCA), tested on 80 patients in a randomized, double-blind, placebo-controlled study, has been shown to help people lose weight safely. Patients who took Super CitriMax also increased their serum serotonin levels (thus curbing their appetite) and decreased their serum leptin levels (better regulating obesity). The maker of the product is InterHealth Nutraceuticals, Benicia, Calif., (707) 751-2800.

Rugby Laboratories, Duluth, Ga., (678) 584-5678, a subsidiary of Watson Pharmaceuticals, is expanding its line of products to include Watson's nicotine polacrilex gum, in 2-mg and 4-mg strengths, as an aid in smoking cessation. The company is offering the gum as an alternative to GlaxoSmithKline's OTC Nicorette gum.

For cough sufferers, DexAlone (dextromethorphan hydrobromide, 30 mg), an antitussive from Xanodyne Pharmacal, Florence, Ky., provides tough cough control in a gelcap. The product offers the highest level of dextromethorphan allowed without a prescription and is said to produce no narcotic side effects at the recommended dose. For further information, call (859) 371-6383.

In support of normal sleep patterns, there is Knock-Out, from Schiff, Salt Lake City, (800) 526-6251. The product contains 100 mg of valerian extract, 50 mg of L-theanine (an amino acid and the primary ingredient in green tea), 3 mg of melatonin, and 0.8 mg of valerenic acids. One tablet at bedtime is said to provide the relaxation needed to promote sleep.

From Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conn., (203) 798-4700, comes Pharmaton Natural Health Products, a line of dietary supplements, in new packaging. Sporting the new look are Ginsana, Ginkoba, Ginkoba Mental Endurance, Venastat, Prostatonin, and Kyolic. Supplifem, a blend of soy complex and red clover extract to help ease transition through menopause, is being added to the line.

From St.-Louis-based ZeaVision L.L.C., (888) 875-3937, comes a dietary supplement containing zeaxanthin to help prevent or impede the progression of macular degeneration. The ZeaVision formula, available in 3-mg and 10-mg strengths, provides a strong antioxidant with light-filtering properties to protect the eyes from damaging effects of sunlight.

A new dietary supplement is available for the special needs of cardiovascular patients. Essentum, from Vital Living, Tempe, Ariz., is formulated to complement other physician-directed treatments, such as drug therapy and lifestyle and diet changes, while at the same time avoiding conflict with other medications the patient may be taking. For further information, call (561) 881-7318.

For patients with excess salivary gland secretions (sialorrhea), QR-334, from Quigley Corp., Doylestown, Pa., (267) 880-1100, may offer relief from this potentially life-threatening condition. The company is working with associations representing ALS, Parkinson's, and other relevant illnesses to foster consumer awareness of the medication.

Move Free Triple Strength joint care now supplies 1500 mg of glucosamine and 1200 mg of chondroitin in two coated tablets (as opposed to three tablets in the original formula) for the support of joint cartilage and joint function. The product, from Schiff, Salt Lake City, (801) 975-5000, will be available in 80-count bottles.

McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, Pa., (215) 273-7000, is launching Tylenol Cold Day/Night and Tylenol Sinus Day/Night convenience packs. Each combination pack contains two formulas: non-drowsy caplets for daytime use and nighttime caplets with antihistamine to ease the discomfort of cold and sinus symptoms.

Home Health Care

The FDA has granted marketing clearance for an anti-microbial Hydrofiber wound dressing. AQUACEL Ag, effective against a broad spectrum of wound pathogens, helps reduce infection for acute and chronic wounds, including partial-thickness burns; surgical wounds; and diabetic foot, leg, and pressure ulcers. The product's gelling mechanism provides a moist wound environment, and its fluid handling properties contribute to longer wear time, fewer dressing changes, and thus lower overall wound care costs, according to the company. ConvaTec, a Bristol-Myers Squibb company, can be reached at its Princeton facility, (800) 422-8811.

Q-tips Treat & Go is a first-aid antibiotic bacitracin ointment and cotton swab, from Unilever HPC U.S.A., Greenwich, Conn., (203) 625-1130. Each single all-in-one packet, for pocket or purse, contains a swab and the ointment in side-by-side compartments. Fifteen packets make up a box.

The Bath+Safe Elevated Toilet Seat with Arms, from Maddak Inc., Pequannock, N.J., (973) 628-7600, fits most toilets and provides support for up to 300 lb. The three-and-a-half-in. riser attaches to the toilet and uses a standard toilet seat and lid ... Also from Maddak is the Ableware Children's Chaise child seat for the bath or beach. It comes in two colors, with a carry handle, a holder for a hand shower, and a bar of soap. The four-position headrest can be set to accommodate different-sized children—or even small adults ... Another new item is the Scooper Plate, designed to help children and adults with limited muscle control or the use of only one hand eat from a plate. The bottom of the dish is held in place with a rubber suction base.

 

Nancy Jillard. New Product Newswire. Drug Topics 2002;18:88.