New Rx, OTC, and generics (January 2010)

January 15, 2010

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

Key Points

RX CARE

New drugs

Arkray has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new Glucocard Vital blood-glucose monitoring system. Said to be highly accurate, the new Glucocard Vital meter and strip platform is auto-coded, requires only 0.5 microliter of blood, holds 250 downloadable tests in its memory, and has a glucose oxydase (GO) strip chemistry that is not affected by interferences that cause testing errors in other common test strips. Visit http://www.glucocardusa.com/ for more information.

NeurogesX announced that the FDA has approved the Qutenza (capsaicin) 8% patch, the only product containing prescription-strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain that can follow shingles. Qutenza delivers a synthetic form of capsaicin through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. Visit http://www.Qutenza.com/ for more information.

Shire has made available Intuniv (guanfacine extended-release tablets), a selective alpha-2A adrenergic receptor agonist, for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years of age. Intuniv is not a controlled substance and has no known potential for abuse or dependence. Intuniv is available in 1 mg, 2 mg, 3 mg, and 4 mg dosage strengths. Call 800-536-7878 or visit http://www.intuniv.com/ for more information.

New generics

Mylan announced that its subsidiary, Matrix Laboratories Limited, has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals' proton pump inhibitor Prevacid DR Capsules. Find more information at http://www.mylan.com/.

Covidien announced that its subsidiary, Mallinckrodt, has received FDA approval of its ANDA for Oral Transmucosal Fentanyl Citrate (CII). Covidien's product is a generic alternative to the branded Actiq. It is a solid formulation of fentanyl that resembles a lozenge on a handle. See http://www.covidien.com/ For more information.

New indications

Amylin Pharmaceuticals and Eli Lilly have announced that the FDA has approved an expanded indication for Byetta (exenatide) injection. Byetta is now approved for use as a stand-alone medication to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control. For more information call 800-868-1190 or visit http://www.amylin.com/.

The FDA has approved Pfizer's Geodon (ziprasidone HCl) capsules for the maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. Geodon is already approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia. For more information call 800-438-1985 or visit http://www.geodon.com/.

OTC

Bayer Consumer Care has made available Citracal Calcium Plus Heart Health as a dietary supplement to support bone and heart health. Citracal Calcium Plus Heart Health contains calcium and vitamin D to support calcium absorption, along with phytosterols, a natural plant ingredient that may reduce the risk of heart disease by lowering cholesterol. For more information, call 866-511-9328 or visit http://www.citracal.com/.

Novartis Consumer Health announces its over-the-counter Prevacid 24HR (lansoprazole delayed-release capsules 15 mg/acid reducer). The medication treats frequent heartburn, which is defined as heartburn occurring two or more times per week. Prevacid 24HR is the first and only over-the-counter (OTC) proton pump inhibitor (PPI) for the treatment of frequent heartburn in its original formulation. Visit http://www.Prevacid24HR.com/ for more information.

Cabot Labs offers P.O.L. Cream to hydrate and rejuvenate vulnerable skin. The company calls it ideal for multiple skin-care challenges, including diabetic skin-and-foot care. The formula contains six moisturizing agents and restorative ingredients to promote an environment for healthy, protected skin. The nonstaining product is said to calm itch, eliminate heel fissures, and combat bedsores. Call 800-645-5048 for more information.

To protect users from more than 160 germs, viruses, and bacteria, including Influenza A, A2, H3N2, e-coli, and all staph infections, RGE Products offers Microsan Anti-Microbial Foaming Hand and Skin Sanitizers, Lotions, and Soap Disinfectants. Microsan products provide a long-lasting (up to 6 hours) residual anti-bacterial, -viral, -flu, and -yeast protection, even after repeated hand washing. For more information on these antimicrobial products, http://www.rgeproducts.com/.