new products for March 5 issue/2001
Serono Inc., Norwell, Mass., (781) 681-2340, is launching two fertility products for which it received an earlier FDA approval. Ovridel (choriogonadotropin alfa for in-jection) is prescribed to women undergoing infertility treatment and is used after ovarian stimulation with follicle-stimulating hormone in those undergoing assisted reproductive technologies (ART). It is also used to trigger ovulation in infertile women with ovarian dysfunction. According to the company, it is the only recombinant human chorionic gonadotropin (hCG) available in the world and the only hCG approved for administration by subcutaneous injection in the United States. Cetrotide (cetrorelix acetate for injection) is a gonadotropin-releasing hormone (GnRH) antagonist for prevention of premature ovulation in women undergoing controlled ovarian stimulation for ART. It offers the flexibility of a single 3-mg dose or daily 0.25-mg doses over five to seven days by subcutaneous injection, thereby reducing treatment duration and number of injections compared with conventional infertility therapies.
Supartz (sodium hyaluronate), from Smith & Nephew Orthopedics, Andover, Mass., (978) 749-1000, has received FDA approval for treatment of osteoarthritis of the knee. The product, a clear, viscous liquid, is injected directly into the knee to supplement the natural synovial fluid weakened by osteoarthritis.
StuartNatal Plus 3, a new prenatal vitamin, is available from Integrity Pharmaceutical Corp., Fishers, Ind., (800) 823-6878. According to the company, which acquired the StuartNatal line from Wyeth-Ayerst last year, the prenatal vitamin formulation meets all USP standards for quality, potency, purity, and dissolution for all active ingredients, including folic acid. It incorporates three new features to combat nausea: less iron, increased vitamin B6, and no artificial dyes or flavorings.
For those patients with type 2 diabetes whose blood glucose is not controlled by diet and exercise, Starlix (nateglinide), from Novartis Pharmaceutical Corp., East Hanover, N.J., is now available nationwide. The drug, a D-phenylalanine derivative for use as monotherapy or in combination with metformin, was approved by the FDA in December 2000. Starlix stimulates rapid, short-acting insulin secretion that reduces the post-mealtime glucose spikes that contribute to worsening overall blood glucose control. For further information, call (877) STARLIX.
Bedford Laboratories, Bedford, Ohio, (440) 232-3320, has begun the marketing of a "10-pack" configuration of GlucaGen (glucagon [rDNA origin] for injection). The product is used to relax smooth muscles in the gastrointestinal tract in order to improve the quality of images viewed during radiological exams. It is used as well in the treatment of severe hypoglycemia in insulin-dependent diabetics, causing the liver to release glucose by stim-ulating the conversion of glycogen to glucose. GlucaGen was developed by Novo Nordisk Pharmaceuticals and is marketed in the United States by Bedford.
Mylan Laboratories, Pittsburgh, (412) 232-0100, has received tentative approval for famotidine tablets, 20 mg and 40 mg. The product provides a generic alternative to Merck's Pepcid tablets and is indicated for the long-term treatment of active duodenal ulcers and the long-term treatment of gastroesophageal reflux disease.
Barr Laboratories, Pomona, N.Y., (845) 362-1100, has been granted FDA approval for several new products. Fluvoxamine maleate tablets, in 25-, 50-, and 100-mg strengths, offer a generic alternative to Solvay Pharmaceuticals' Luvox tablets, indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder. Barr has also received approval for its dextroamphetamine sulfate tablets, 5 mg and 10 mg, providing a generic alternative to Shire Richwood's Dextrostat tablets. The agent is indicated for narcolepsy and attention deficit disorder with hyperactivity. Amiodarone hydrochloride tablets, 200 mg, Barr's generic equivalent to Wyeth-Ayerst Laboratories' Cordarone tablets, also received FDA approval. The drug is indicated for treatment of various life-threatening recurrent ventricular arrhythmias that have not responded to other available antiarrhythmics or when alternative agents could not be tolerated.
Generic Procardia XL (once-daily nifedipine), 30 mg, has received final approval from the FDA. The product, from Biovail Corp., Toronto, (416) 285-6000, is indicated for treatment of hypertension and angina. The company had previously received approval for its 60-mg dosage strength of the generic formulation. Procardia XL is a product of Pfizer Inc.
Watson Pharmaceuticals, Corona, Calif., (909) 270-1400, has received approval for Microgestin Fe 1.5/30 tablets (norethindrone acetate and ethinyl estradiol tablets USP, 1.5 mg/0.03 mg tablets and ferrous fumarate tablets, 75 mg) and Microgestin Fe 1/20 tablets (norethindrone acetate and ethinyl estradiol tablets USP, 1.0 mg/0.02 mg and ferrous fumarate tablets, 75 mg). Both Microgestin Fe 1.5/30 and Microgestin Fe 1/20 tablets are said to be therapeutically equivalent to Parke-Davis' Loestrin Fe 1.5/30 and Loestrin Fe 1/20 tablets, respectively. The products are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Watson Pharmaceuticals has also received FDA approval for 100-mg morphine sulfate extended-release tablets. They offer a generic alternative to Purdue Frederick's MS Contin controlled-release tablets, indicated for controlling moderate to severe pain.
FDA approval has been given to Eon Labs Manufacturing, Laurelton, N.Y., (718) 276-8607, for oxaprozin tablets, 600 mg. This approval provides a generic alternative for Searle's Daypro, an arthritis medication.
Three new products are now available from Apotex Corp., Weston, Fla., (202) 955-6222. The company has received FDA approval for betaxolol HCl 0.5% ophthalmic solution. The product is generically equivalent to Alcon Laboratories' formerly marketed Betoptic, indicated for lowering intraocular pressure. Apotex has also been granted approval for levobunolol HCl 0.5% ophthalmic solution, a generic alternative to Allergan's Betagan Ophthalmic Solution, an antiglaucoma drug; and for timolol maleate 0.25% & 0.5% ophthalmic solution, a generic alternative to Merck's Timoptic, also indicated in the treatment of elevated intraocular pressure.
GlaxoSmithKline, Research Triangle Park, N.C., (888) 825-5249) is introducing TUMS Calcium for Life PMS and TUMS Calcium for Life Bone Health. According to GSK, the products were created in response to scientific evidence that the calcium carbonate found in TUMS can help reduce the effects of premenstrual syndrome (PMS) and, in ad-dition, help keep bones healthy. For further information, call (800) 366-8900.
Closure Medical Corp., Raleigh, N.C., (919) 876-7800, has received approval for over-the-counter sales for Liquiderm, its liquid adhesive bandage. The product, called a cyanoacrylate medical device, is painted over a wound and gradually sloughs off as the wound heals.
AlphaRx Inc., Richmond Hill, Ont., (905) 762-0745, is launching Phystrol E and LipoBlock, two new dietary supplements with fully solubilized plant sterols or phytosterols for the management of high cholesterol.
Healthpoint, Ltd., Fort Worth, Tex., (817) 900-4000, has introduced TheraSeal Hand Protection to prevent and protect against hand eczema and dermatitis. The product contains dimethicone and cyclomethicone as well as aluminum magnesium hydroxide stearate and comes as a nongreasy and longlasting cream.
New from Personal Products Corp., Skillman, N.J., (800) 782-4051, is an updated Monistat 3 combination pack. The original product, which has been on the market since 1996, contains a suppository for the treatment of yeast infection internally and a cream to treat external itching. The new vaginal yeast infection treatment substitutes a cream-filled applicator for the suppository. Both creams contain the active ingredient miconazole nitratewith the internal cream formulated at 4%, the external cream at 2%.
New this month is Surpass, an antacid chewing gum from Wrigley Healthcare that relieves both heartburn and acid indigestion. Available in regular and extra strength, the gum comes in two flavorscool wintergreen and fruit. Surpass is packaged in 10-piece blister packs, 20- or 30-piece blister multipacks, and 45- or 60-piece bottles. The company, a new division of Wm. Wrigley Jr. Co., Chicago, claims that the antacid works even after one stops chewing the gum. For more information, call (866) SURPASS.
Maddak Inc., Pequannock, N.J., (973) 628-7600, is introducing its Ableware Halo Cup, which has a wide, circular, tip-resistant base. The cup also has a special handle for easy gripping. The suggested retail price is $2.75.
From Beiersdorf Inc., South Norwalk, Conn., (203) 854-8000, come two products to promote the healing of minor wounds. Curad Wound Wipes help clean cuts, scrapes, and burns and fight germs with the antibacterial benzalkonium chloride. These thick, moist, alcohol-free pads are individually sealed and are available in boxes of 14 at a retail price of $2.79. Curad Hydro Heal bandages support moist wound healing by retaining the skin's natural moisture level as they protect wounds against water, dirt, and germs. The slim, breathable bandages, individually wrapped, come in assorted sizes in boxes of 10. The average retail price is $3.59. Also available from the company are Curad Scar Therapy Cosmetic Pads, for reducing the visibility of raised and/ or colored scars, old or new. They have a suggested retail price of $16.99.
Naturistics has introduced Glitter Stixx, body glitter pencils that enable the user to highlight shoulders and arms, cheek bones, and brow bones with sparkles. The suggested retail price is $2. For more information, call (516) 844-2048.
From L'Oreal, New York, N.Y., (212) 984-4109, comes Ombrelle SPF 44 Lotion for Kids. The product, which has broad-spectrum UVA and UVB protection and a nonstinging formula, was specially developed for children's delicate skin. The suggested retail price is $8.99 for 4 oz. of lotion.
Also from L'Oreal is L'Oreal Plenitude Revitalift Complete. The product was designed to offer the ultimate in antiaging formulations, antiwrinkling, and firming, coupled with SPF 18 broad-spectrum UV-ray protection. For a 1.7-oz. jar, the suggested retail price is $11.99.
Procter & Gamble, Cincinnati, (513) 945-9845, is marketing its Physique Style Achievement collection, which includes hairstyling appliances to complement its line of Physique hair products. There's a volumizing hair dryer and three-quarter-inch curling iron to match the volumizing series of shampoos, conditioners, foams, and sprays. Additionally, there's a straight-shape hair dryer and curling iron to match the straight-shape hair treatments. Dryers have a suggested retail price of $24.99; curling irons are priced at $14.99.
Cover Girl Outlast All-Day LipColor is new from Procter & Gamble's Cover Girl division, Hunt Valley, Md., (410) 785-7300. This two-step system employs an all-day colorcoat and a moisturizing topcoat; they are sold together at a retail price of $9.50. The product is available in 26 shades.
Ultima II, New York, N.Y., (212) 527-6012, a subsidiary of Revlon Inc., is adding to its product lineup this year. New are Glowtion Highlighting Souffle, for a glowing skin look ($17.50 for a 0.5-oz. jar); Pucker & Pout Flowing Lipstick, with moisturizing vitamins A, C, and E ($12.50 each); and Glowtion No Color Skin Brightening Moisturizer ($21.50 for a 2-oz. bottle).
Almay, another subsidiary of Revlon, New York City, (212) 527-4000, is introducing several new beauty products. Among them are Milk Plus, a facial care collection fortified with calcium, milk proteins, and milk lipids; Fluoride Plus nail care and nail color, fortified with organic fluoride; WAKE-UP CALL! makeup and concealer; and Naturalist eye defining pencil, offering vitamins A and C.
CCL Container Tube Division, Oak Ridge, N.J., (973) 208-7305, is introducing a new five-eighth-inch diameter laminate tube with an eye-tip dispenser. The product is designed for use with eye creams and cold sore remedies.
Play-By-Play Toys & Novelties, San Antonio, (210) 829-4666, has introduced a number of new products. Among them are a line of 10 bendable, posable soft dolls called Hook-Ups, with names such as Britney, Roxie, and Harmonie, retailing for $7.99 each; a line of Micro Fightersmodels of the Stealth Fighter and the Apache Attack Chopper, for $4.99 each; and a line of International City Sign Dolls, each representing a popular vacation destination, such as France, Spain, and Italy.
Planet Rascals, El Segundo, Calif., (310) 322-7006, is launching new educational software that teaches children about animals and their environment. Each CD-ROM introduces the child (ages six to 10) to one of six animals and comes with a cuddly plush replica. The suggested retail price is $24.95.
Endless Games, Hoboken, N.J., (201) 386-9465, will reintroduce "What's My Line?" The popular TV show that ran for 17 years challenges players to guess a guest's line of work by asking questions. The game will retail for a suggested price of $24.99.
Who, where? ExploraToy is introducing a number of science/nature toys. Among them are: Amazing Live Sea-Monkey Explor-A-Sub, an interactive device that utilizes a water container, a water purifier, live sea monkey eggs, retailing for $14.95; an Amazing Life Sea-Monkeys MagiQuarium that glows in the dark and retails for $6.95; GeoSafari Bug-Cam and Aqua-Cam, which enable a child to enlarge captured live insects or aquarium life, respectively, on the home video screen or VCR, retailing for $79.95; GeoSafari Talking Microscope, retailing for $29.95; and GeoSafari Sea Search, a map of the ocean floor and audio answers to recorded questions, retailing for $49.95. Most toys are for children ages five to eight and older.
Ralph Thurlow. New Product Newswire. Drug Topics 2001;5:108.