New products: Rx, generic, OTC (February 2009)

February 1, 2009

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

Key Points

New Drugs

The Food and Drug Administration approved Abbott's Trilipix (fenofibric acid), delayed-release capsules for use with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin. Visit http://www.trilipix.com/ or call Abbott Medical Information at 800-633-9110 for more information.

The FDA has granted Pfizer's Selzentry (maraviroc) full (traditional) approval for use in combination with other antiretrovirals in treatment-experienced adults with CCR5-tropic HIV-1. Selzentry now becomes the latest fully approved treatment for HIV. More information on the approved U.S. label is available at http://www.selzentry.com/.

Ligand Pharmaceuticals announced recently that the FDA has granted accelerated approval of GlaxoSmithKline's Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. For more product information, call 310-691-7100 or e-mail dmarkley@lhai.com
.

Eisai Corporation of North America announced that the FDA has approved Banzel (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 4 years and older. Eisai received a complete response letter for Banzel's use as an adjunctive treatment for partial-onset seizures with and without secondary generalization in adults and adolescents 12 and older. For more information about Banzel, go to http://www.eisai.com/product.asp?ID=268/.

New Indication

Schering-Plough announced the FDA has granted marketing approval to Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) combination therapy for use in previously untreated patients 3 years and older with chronic hepatitis C. This represents the first and only approved combination of peginterferon and ribavirin for treating pediatric hepatitis C. See full US prescribing information and the medication guide for Pegintron at http://www.schering-plough.com/.

New Generics

IMPAX Laboratories announced the FDA granted final approval of the company's ANDA for a generic version of Wellbutrin XL 150 mg extended-release tablets. GlaxosmithKline markets Wellbutrin XL for the management of depression. Contact products@impaxlabs.com
for information.

Lannett announced that it has received approval from the FDA of its ANDA for Ursodiol 300 mg capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals. Ursodiol is indicated for patients with radiolucent noncalcified gallbladder stones and for the prevention of gallstone formation in obese patients experiencing rapid weight loss. For more information, visit http://www.lannett.com/.

BTC

Promius Pharma has launched Scytera (coal tar) Foam 2%, for the treatment of chronic psoriasis. Scytera's foam technology allows the product to be spread easily and smoothly over large body areas. Visit http://www.scyterafoam.com/ for more information.

OTC

EyeScience Labs announces the availability of its advanced ocular nutrition line for age-related macular degeneration (AMD) and dry-eye syndrome. EyeScience Macular Health Formula is an eye vitamin supplement specifically for AMD. For more information, contact Jeff Northup, 614-577-0099, jnorthup@eyescience.com
.

NailTek has introduced an advanced nail-care product: Citra Formaldehyde Free, a nail strengthener containing a citrus-based natural aldehyde alternative to formaldehyde. For more information visit http://www.nailtek.com/.

Marlenk Innovations announces the introduction of Spray'n Swallow, an all-natural way to help people swallow pills. The product lubricates the throat and helps pills glide down. Call 888-877-7294 or visit http://www.spraynswallow.com/ for more information.