New products: Rx, Generics, OTC, HBC (October 2008)

Rx

New Drugs

Promius Pharma, a wholly-owned subsidiary of Dr. Reddy's Laboratories Inc., has launched EpiCeram Skin Barrier Emulsion, the first prescription medical device cream for the treatment of atopic dermatitis that, in a clinical trial, has shown efficacy-comparable to that of a mid-potent corticosteroid. EpiCeram is a physiologic, ceramide-dominant, lipid-based first-line treatment that provides an optimum ratio (3:1:1) of ceramides, cholesterol and free fatty acids to repair a defective skin barrier of atopic skin. Available by prescription only from dermatologists. To obtain more information visit http://www.promiuspharma.com/.

Millennium Pharmaceuticals, the Takeda Oncology Company, and Takeda Pharmaceutical Co. Ltd. have announced approval by the U.S. Food and Drug Administration of Velcade (bortezomib) for patients with previously untreated multiple myeloma (MM). The company states the clinical trial showed 30 percent complete remission rate with bortezomib compared to 4 percent for the control arm. For more information visit http://www.millennium.com/.

New Generics

American Health Packaging recently added new SKUs to its unit-dose line. They include Bupropion HCI XL 300 mg tablets (AB3-rated to Wellbutrin XL), Glipizide Tablet ER 5 mg and 10 mg tablets (AB-rated to Glucotrol XL), and Cabergoline .5 mg tablet (AB-rated to Dostinex). All American Health Packaging unit-dose items are bar-coded to the dose. They are stocked by the major wholesalers and are awarded to the GPOs. For information call (800) 707-4621 or visit http://americanhealthpackaging.com/.

Taro Pharmaceutical Industries Ltd. has received final FDA approval for its Abbreviated New Drug Application for prescription Cetirizine Hydrochloride Syrup, 1 mg/1 ml ("cetirizine syrup"). Cetirizine syrup is bioequivalent to McNeil Consumer Healthcare's Zyrtec Syrup. Cetirizine syrup is used for the relief of symptoms associated with perennial allergic rhinitis in children 6 to 23 months of age and for chronic urticaria (hives) in children 6 months to 5 years of age. For more information visit http://www.taro.com/.

Lupin Limited announced that its subsidiary in the US, Lupin Pharmaceuticals, Inc., has received tentative FDA approval for its Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg. Lupin's Escitalopram tablets are the AB-rated generic equivalent of Lexapro tablets, indicated for the treatment of major depressive disorder. For more information e-mail seemaahuja@lupinpharma.com
or call +919920042046 022 66402323, ext. 2531.

Roxane Laboratories, Inc. has received FDA approval for the Abbreviated New Drug Application (ANDA) for Ramipril Capsules 1.25 mg, 2.5 mg, 5 mg, and 10 mg. Ramipril Capsules are AB-rated to Altace (ramipril) Capsules. Roxane Laboratories' Ramipril Capsules are indicated for the treatment of hypertension. For more information, go to http://www.roxane.com/.

OTC

Medi-Dose announces a new enhancement to the Medi-Dose unit-dose packaging line - Oval Medi-Cup Blisters and accompanying Lid-Label Cover Sheets. These new additions have been specially designed for storage in virtually all existing equipment that dispenses medication. According to the company, there is no sacrifice in tamper-evidence, moisture resistance, ultraviolet inhibitance or beyond-use dating. With the MILT 3.0 software bar codes, graphics, special fonts, Tall Man lettering, shapes and logos can all be included on labels. For more information, e-mail info@medidose.com
.

Comar Inc. ( http://www.comar.com/accucup/) has launched AccuCup, the first commercially available dosage cup with measurement markings printed on the outside of the cup with cured and durable, FDA-compliant food-grade inks. AccuCup is a safer alternative to embossed dosage cups, particularly in liquid-drug dispensing applications. AccuCup is now being offered to the general and pediatric market with the flexibility to fit child-resistant closures 22 mm-24 mm in diameter. AccuCup will be available in a "Stock-Standard Cup" design with generic markings of up to 20 mL and 4 tsp.

ETC.

New, tiny, mercury-free hearing aid batteries from Energizer ( http://www.energizer.com/) arrive in the U.S. market this month. Currently, all zinc air hearing-aid batteries sold in the United States contain mercury. Through a combination of new designs, purer raw materials and new manufacturing processes, Energizer's R&D scientists are now able to produce cells with zero mercury.

HBC

Tom's of Maine ( http://www.tomsofmaine.com/) is making available a new line of Sensitive Care aluminum-free deodorants, offered in three scents: Bay-Lime, Cucumber-Grapefruit and Fragrance-Free. The deodorant employs a method called supercritical extraction to draw out the most effective elements from hops, which inhibit the growth of odor-causing bacteria and prevent odor naturally and effectively. The products are dermatologist-tested for sensitive skin.

Olivella introduces Olivella Bath and Shower Gel to help create an at-home spa in the bathtub or shower. The gel, which has a light citrus scent, turns into a creamy lather designed to nourish and moisturize the skin while it cleanses. The formula is made with 100 percent natural virgin olive oil and high concentrations of natural vitamins, essential fatty acids, and antioxidants. Ingredients such as squalene, Vitamin A, Vitamin E, and polyphenols give the gel hydrating properties, while the olive oil has anti-aging properties. Visit http://www.olivellasoap.com/ for more information.