Hair Loss News

CORAL GABLES, Fla., – Stiefel Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina(R) (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis. The approval, which the company received June 12, clears the way for the product to be sold and marketed in the United States.

Different from other treatments for seborrheic dermatitis, which contain ketoconazole 2% in a cream, gel or shampoo vehicle, Extina is administered using VersaFoam(R) HF(R) (hydroethanolic formulation) technology, a unique, versatile topical drug delivery vehicle that is quickly absorbed into the skin. Extina Foam proved to be superior to placebo foam in a Phase III clinical trial. Of subjects receiving Extina (R) Foam, 56% achieved treatment success based on an Investigator Global Assessment compared to 42% of subjects receiving vehicle foam. Stiefel Laboratories, the world’s largest independent pharmaceutical company specializing in dermatology, acquired the proprietary VersaFoam HF technology with its December 2006 acquisition of Connetics Corporation.

“We are very pleased with the robust data obtained in the pivotal Phase III clinical trial evaluating the safety and efficacy of Extina,” said Jim Hartman, Senior Vice President, U.S. Commercial Operations for Stiefel Laboratories. “It is exciting that this product, combining the proven efficacy of ketoconazole 2% in the patient-preferred foam delivery system will soon be available for patients with seborrheic dermatitis. It will provide dermatologists and other allied health professionals with an additional treatment option for this condition and allow patients to choose their preferred drug delivery method.

“Extina is representative of the robust and innovative product pipeline at Stiefel Laboratories,” Hartman added.

Stiefel Laboratories plans to launch the product, which will be available only by prescription, in August this year.  Extina(R) (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Extina should be applied to the affected skin areas twice a day (morning and evening) for four weeks. Extina is administered via VersaFoam HF, which studies show offers consistent skin permeation, drug distribution and drug delivery. Additional patient benefits include versatility (Extina can be used on hair bearing and non hair-bearing skin), it absorbs quickly and it is non-drying with no residue.

Ketokonazole is the active ingredient in Nizoral shampoo and is used by many hair loss sufferers because studies have shown that it’s beneficial in treating hair loss.

For more information about Extina, please visit http://www.extina.com/.

The U.S. Food and Drug Administration announced new rules requiring that dietary supplements are to be tested to ensure that they are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.   These standards are known as good manufacturing practices (cGMP) and are already used in food manufacturing.

“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

“The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

• Read more: FDA issues new dietary supplements rule

Actavis, a drug manufacturer based in Iceland, has just received approval from the U.S. Food & Drug Administration to market generic Finasteride Tablets, USP 5 mg.

Finasteride 5mg tablets are the generic equivalent of Merck & Company’s Proscar® tablets which are indicated for the treatment of benign prostatic hypertrophy (BPH).

Finasteride in a 1mg tablet version is sold under the brand name Propecia® for use in treating hair loss.   In order to save money, some men buy Finasteride 5mg tablets and then cut them into fifths with the aid of a pill splitter.   Although doctors frown on this practice, it has become more common due to the rising cost of Propecia, which at this time is not available as a generic. 

For men who use Proscar® or one its generic equivalents, this new approval is good news because the more suppliers there are, the lower prices will drop.   Obtaining Proscar or its generic equivalent requires a doctor’s prescription since it’s only been approved as a treatment for benign prostatic hypertrophy (BPH), not hair loss.

According to IMS Health data Annual, the sales of Finasteride 5mg tablets in the U.S. were approximately US$364 million for the twelve months ending March 2007.

It is expected that the distribution of the new generic will begin immediately.

Learn all about generic drugs in this informative article from the FDA.

What are generic drugs?

A generic drug is the same as a brand-name drug in:

• dosage
• safety
• strength
• quality
• the way it works
• the way it is taken
• the way it should be used

• Read more: What is a generic drug and how does it differ from FDA approved drugs?