Approved by the FDA late last year, Tracleer (bosentan), from Switzerland-based Actelion Ltd., has recently been made available to patients in the United States who suffer from PAH, or pulmonary arterial hypertension. Tracleer, an endothelin receptor antagonist, is the first oral medicine to improve the symptoms of this potentially fatal condition. For further information, call (866) 228-3546.
The FDA has approved a new indication for Plavix (clopidogrel bi-sulfate), comarketed by Sanofi-Synthelabo (France) and Bristol-Myers Squibb, Princeton, N.J., (609) 252-4000. The product, an inhibitor of platelet aggregation, is now cleared for treatment of acute coronary syndrome (ACS) in addition to its original indication for the reduction of atherosclerotic events. The FDA decision means that for patients with ACS, physicians now have a medication that can further reduce the acute and long-term risk of future heart attack, stroke, or cardiovascular death on top of current standard therapy, including aspirin.
Alora (estradiol transdermal system) from Watson Pharmaceuticals, Corona, Calif., (909) 493-5611, has been granted both a new indication (prevention of postmenopausal osteoporosis) and a new strength (0.25 mg/ day) by the FDA. The product was previously approved for treatment of moderate to severe vasomotor symptoms associated with menopause and is already available in strengths of 0.05-, 0.075-, and 0.1-mg estradiol per day.
New from McNeil Consumer, Fort Washington, Pa., (215) 273-7000, are Concerta extended-release tablets (methylphenidate HCl) in a 27-mg dosage strength. Concerta, already available in 18-, 36-, and 54-mg strengths, is indicated for the treatment of attention deficit/hyperactivity disorder. The patented OROS delivery system, by means of a trilayer tablet, delivers a controlled rate of medication throughout the day, permitting once-daily dosing in the morning, with or without food.
Uniretic (moexipril hydrochloride and hydrochloro-thiazide) is now available in a 15/12.5-mg dosage strength. According to the manufacturer, Schwarz Pharma, Mequon, Wis., (262) 238-5400, adding a new strength of its ACE inhibitor/diuretic product will provide doctors with greater flexibility in treating patients with hypertension who need control beyond ACE inhibitor or diuretic monotherapy. Uniretic is already available in 7.5/ 12.5-mg and 15/25-mg dosage strengths.
Available from Fougera, Melville, N.Y., (800) 645-9833, is an extension to the company's line of sterile ophthalmic products. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, indicated for the topical treatment of superficial infections of the external eye, provides a generic alternative to Monarch Pharmaceuticals' Polysporin. The ointment is packaged as 1/8-oz. tamper-resistant tubes.
Having received final FDA approval for its generic version of Organon's Mircette oral contraceptive (desogestrel/ethinyl estradiol and ethinyl estradiol), Barr Laboratories, Pomona, N.Y., (800) BARRLAB, will market Kavira. The 28-day tablet regimen is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Approved earlier as the prescription preparation Mentax, Lotrimin Ultra antifungal cream is now available over the counter to sufferers of athlete's foot, jock itch, and ringworm. Formulated with the active ingredient butenafine hydrochloride 1%, it is available as a 12- and 24-gm cream from Schering-Plough HealthCare Products, Berkeley Heights, N.J., (908) 679-1640.
Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, and Ohm Laboratories, subsidiaries of India-based Ranbaxy Laboratories, have received an OK from the FDA for over-the-counter sale of acetaminophen extended-release tablets in 650-mg strength. The approval offers a bioequivalent to Tylenol Arthritis Pain Extended Relief Caplets, from McNeil Consumer Healthcare, used for temporary relief from aches and pains caused by arthritis, common cold, headaches, muscular aches, toothaches, backaches, and menstrual cramps.
A new and improved formulation of A&D ointment is now available from Fougera. The product, babyADE A&D Ointment + Vitamin E, packaged in both single-use pa-quettes and an economy-size tub, has been formulated for the relief of diaper rash irritation and to promote healing.
Providing itch relief for the dry skin associated with eczema and atopic dermatitis is new Eucerin itch-relief moisturizing spray. It is available from Beiersdorf Inc., Wilton, Conn., (203) 854-8000. As the glycerin and dimethicone moisturize, the menthol cools and relieves itching.
Also for relief of itching is NeoStrata's Bionic Lotion, which contains lactobionic acid to exfoliate, plump, and soothe the skin and gluconolactone to diminish the appearance of fine lines and wrinkles. The fragrance-free lotion contains vitamin E to ward off damage from harsh weather or sun exposure.
From Pfizer Consumer Healthcare Group, New York City, (800) 223-0182, comes new BenaMist allergy-prevention nasal spray. The antihistamine-free cromolyn sodium nasal solution prevents and relieves nasal allergy symptoms, including runny, itchy nose; sneezing; and allergic, stuffy nose in patients ages two years and older.
New from 3M Health Care, St. Paul, (800) 447-4537, is a bandage that is claimed to be a cinch to removewithout damaging skin or pulling hair. The flexible 3M Nexcare Ease-Off bandages stretch with the skin, and "micro-vents" allow the skin underneath to breathe. The bandages are available in transparent white and in blue, pink, and green.
For easier access into and out of the bathtub, Maddak Inc., Pequannock, N.J., (973) 628-7600, is offering its Bath+Safe Deluxe Tub Safety Rail. At 14.75 in. high, it features a nonmetal, easy-grip handle and rubber pads to protect the tub from scratches. It fits tubs with sides three to seven inches in thickness and retails for $43.90.
Also from Maddak is the Ableware adjustable transfer bench to assist those who find it difficult to get in and out of the bathtub or shower. It adapts to either left- or right-hand tub/shower entry. Height-adjustable legs straddle the edge of the tub and come with suction feet to hold them steady. Back and arms are removable.
For treating acne beyond the teen years, new anti-aging Alpha Clear, from Niora, Sweet Home, Ore., (800) 882-9887, provides a natural, fruit-derived alpha hydroxy-based acne treatment that also moisturizes the skin to help prevent wrinkles. The two-step system is formulated to clean, tone, and moisturize as it encourages the natural healing of acne and reduction of wrinkles and age spots.
Procter & Gamble, Cincinnati, (800) 347-1565, has come out with several additions to its Physique product lineup. For wavy, curly, or permed hair, lightweight Physique Scrunching Foam is set to add shine to hair and make curls and waves more manageable. Physique Trial Size Packettes contain Spiral Cream and Contouring Lotion in one travel-size package. In addition, the Physiques line offers the new Curl Defining Hair Dryer, for creating curls and waves; the Curl Defining Hair Setter, with 18 curling rods and a lighted makeup mirror; and the Straight Shape Hair Dryer for straightening and smoothing hair.
New from Sally Hansen, Farmingdale, N.Y., (516) 844-2020, is Diamond Strength instant nail hardener, offering a shatterproof protective coating that reconstructs damaged and weakened nails. A line of advanced hand care offers Radiant Hands, Nails, and Cuticle Crème, formulated for rough hands, dry cuticles, and weak nails; and No-Heat Paraffin Hand Smoother, which exfoliates to polish away dry, rough skin. For the woman anxious to combat the signs of aging, there are Age Correct Retinol Hand Crème, which penetrates the skin surface to firm, tone, and protect; Age Correct Growth Treatment Anti-Aging Nail Treatment, to keep nails looking healthy; and Age Correct Growth Treatment, with rose oil and soy extract to promote longer nails that resist breaking.
Introducing new shades for spring and summer is Max Factor, Hunt Valley, Md., (410) 785-7300. Four additions to the Lipfinity line are the frosty lilac Innocent, a rich pink Sweet, a sultry red Frivolous, a warm chestnut Enthusiastic, and a deep mauve Powerful. Six new shades of Lasting Color Eye Shadow and Lasting Color Lipstick offer women a new look appropriate for business and fun.
Two new Skintimate shave gels have been added to the product line from SC Johnson, Racine, Wis., (800) 494-4855. The latest additions include Skintimate Passion Fruit Moisturizing Shave Gel and Skintimate Tropical Splash Moisturizing Shave Gel. Both products contain pro vitamin B, vitamin E, and sunflower oil, along with emollients and lubricants.
E. T. Browne Drug Co., Englewood Cliffs, N.J., (877) PALMERS, is introducing a new skin care line, Palmer's Shea Butter Formula products. The line includes three products: Palmer's Shea Butter Formula Original Jar, an intensive moisturizer for softening and hydration; Palmer's Shea Butter Formula Lotion, an all-over body moisturizer with vitamin E; and Palmer's Shea Butter Formula Swivel Stick, a portable shea butter product that moisturizes dry, damaged skin.
Two new products are available from Procter & Gamble's Cover Girl, Hunt Valley, Md., (888) COVERGIRL. Fresh Complexion Oil Control Makeup is a powder foundation formulated to provide oil and shine control in the T-zone without drying the skin. It is available in 15 shades in a palm-sized compact that stores the sponge applicator separately from the foundation. Fresh Complexion Under Eye Concealer contains special skin-brightening pigments to diffuse light, thus minimizing the appearance of dark circles. The formula is lightweight and is available in six shades that blend with the powder foundation.
Cover Girl is also ablaze with new color for spring in its Color Amazed collection. Among its offerings are Liquid LipSlicks, a liquid lip gloss, with a vanilla scent, in five colorsviolet glaze, rosy glaze, aqua glaze, spring glaze, and pure glazeand Cover Girl NailSlicks in bluebird, deep blue sea, papaya shake, very berry, and lime blossom.
New from L'Oreal, New York City, (212) 818-1500, are three products for life in the sun. Ombrelle Sunscreen Sport Spray (SPF 15) provides convenient spray-on sunscreen for sports fans year-round. A 360-degree pump offers easy appli-cation for hard-to-reach areas and provides broad-spectrum Parsol 1789 UVB/ UVA protection. The product is noncomedogenic, nonsticky, and water resistant. Spray on Ombrelle Sunless Sprays (SPF 12), in both medium and dark, for an overall even color as well as for protection from the sun. The formula is fast- drying and streak-free, providing color in less than one hour. For the face, there's Ombrelle Sunless Tanning Cream (SPF 15), in tinted and clear, adding a healthy glow to sun protection.
Nancy Jillard. New Product Newswire. Drug Topics 2002;9:96.