New Rx, OTC, and generics (December 2009)

December 11, 2009

A survey of new Rx, new indications, and new OTC

Key Points

RX CARE

New drugs

Ferndale Laboratories has launched the Analpram E Kit for treatment and care of hemorrhoids and pruritus resulting from various anorectal conditions. The Analpram E Kit combines prescription strength Analpram E Cream (hydrocortisone acetate 2.5% and pramoxine HCl 1%) with medicated Prax (pramoxine HCl 1%) Wipes. The anorectal cream has been packaged together with a medicated wipe to offer patients convenience in helping to treat the symptoms associated with anorectal pain and discomfort. For more information, call 866-668-7482 or visit http://www.ferndalelabs.com/.

Oculus Innovative Sciences has launched Microcyn Skin & Wound HydroGel. The product is available by prescription for the management of exudating wounds (e.g., leg, pressure, and diabetic ulcers), first- and second-degree burns, and mechanically or surgically debrided wounds. An over-the-counter version is available for management of minor skin abrasions, lacerations, minor irritations and intact skin. For more information, call 678-213-0649 or visit http://www.oculusis.com/.

Daiichi-Sankyo has announced that the FDA has approved Welchol (colesevelam HCl tablets) as an adjunct to diet and exercise to reduce low-density lipoprotein (LDL-C) levels in boys and postmenarchal girls, 10–17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after an adequate trial of diet therapy has failed. In addition, the FDA has approved Welchol (colesevelam HCl) OralSuspension. Welchol is also indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in combination with metformin, sulfonylureas, or insulin. For more information, call 877-437-7763 or visit http://www.welchol.com/.

New indication

The FDA has approved Crestor (rosuvastatin calcium tablets), from AstraZeneca, for use in pediatric patients 10–17 years of age with heterozygous familial hypercholesterolemia (HeFH) after an adequate trial of diet therapy fails. Crestor is already indicated as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in adults with primary hyperlipidemia and mixed dyslipidemia. Crestor is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C and LDL-C to target levels. For more information, call 800-237-8898 or visit http://www.crestor.com/.

Boehringer Ingelheim announced that the FDA has approved a new indication for Micardis (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older who are unable to take ACE inhibitors and are at high risk of developing major CV events. Micardis is the first treatment in its class to be approved for this indication. For more information, visit http://www.boehringer-ingelheim.com/.

OTC

In time for winter weather, Dr. Dobbs' Old Fashioned Natural Remedies offers Perk O' Lips Coffee Flavored Lip Balm, Tantalizing Tangerine Lip Balm, and Peppermint Tingle Lip Balm. These ultra-emollient lip balms offer "gourmet" tastes in a swivel-stick form. Dr. Dobbs' also offers Tomato Complexion Soap, a hand-milled red soap that contains the benefits of natural lycopenes and alpha hydroxy acids derived from tomato to cleanse acne-prone skin and soothe and refine enlarged pores. Visit http://www.drdobbsskincare.com/ for more information.

Female Health Company has made available its FC2 Female Condom, a woman-initiated barrier method that helps protect against unintended pregnancy, HIV/AIDS, and other sexually transmitted infections. FC2 is available from two distributors: Total Access Group and Global Protection Company. Call 800-635-0844 or visit http://www.fc2femalecondom.com/ for more information.

Isopure has launched Isopure Plus, a line of clear, fruit-flavored protein drinks for people requiring extra protein in their diet. Two formulations are available: Isopure Plus Nutritional Drink with carbohydrates, for patients in need of extra calories in their diet, and Isopure Plus Zero Carb Protein Drink without carbohydrates, for weight-loss surgery patients and those with concerns about blood sugar. Call 800-345-2378 or visit http://www.isopureplus.com/ for more information.

Children's Oscillococcinum is a homeopathic medicine that has been shown in clinical studies to help reduce both the duration and the severity of flu-like symptoms. Each dose is packaged individually in a compact and portable plastic tube and is safe to administer to children 2 years of age and older. Parents can easily find this product in the children's aisle. For more information, visit http://www.oscilloinfo.com/.

Organix-South introduces the newest additions to its TheraVeda supplement line, Stress Ease and Sleep Ease, which combine time-proven herbs with advanced extraction technologies to offer consumers fast-acting formulas that are not habit-forming and don't cause drowsiness. They are made with certified organic herbs and vegetarian capsules. For more information, visit http://www.organixsouth.com/ or call 888-989-6336.