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.

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.

The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.

To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

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.

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

 Are generic drugs as safe as brand-name drugs?

Yes.  The FDA says that all drugs must work well and be safe. Generic drugs use the same active ingredients as brand-name drugs and work the same way. So they have the same risks and benefits as the brand-name drugs.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs must be as:

• high quality
• strong
• pure, and
• stable as brand-name drugs

Are brand-name drugs made in better factories than generic drugs?

No. All factories must meet the same high standards. If the factories do not meet certain standards, the FDA won’t allow them to make drugs.

If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other parts may be different. But these things don’t affect the way the drug works and they are looked at by FDA.

Does every brand-name drug have a generic drug?

No. When new drugs are first made they have drug patents. Most drug patents are protected for 17 years. The patent protects the company that made the drug first. The patent doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling the generic version of the drug. But, first, they must test the drug and the FDA must approve it.

What is the best source of information about generic drugs?

Contact your doctor, pharmacist or other healthcare worker for information on your generic drugs. For more information, you can also visit the FDA website at: http://www.fda.gov/cder and click on Consumer Education.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Why are generic drugs less expensive?

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA. Your medication guide should be kept with you and up to date. List your prescription and over-the-counter medicines as well as your dietary supplements.

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical.html.

Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the “Our Websites” heading. Four of these Web sites previously have been identified by FDA’s Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online. Consumers are urged to review the FDA Web page at www.fda.gov/buyonline/ for additional information prior to making purchases of prescription drugs over the Internet.

The 24 Web sites appear on pharmacycall365.com.

AllPills.net
Pharmacy-4U.net
DirectMedsMall.com
Brandpills.com
Emediline.com
RX-ed.com
RXePharm.com
Pharmacea.org
PillsPharm.com
MensHealthDrugs.net
BigXplus.net
MediClub.md
InterTab.de
Pillenpharm.com
Bigger-X.com
PillsLand.com
EZMEDZ.com
UnitedMedicals.com
Best-Medz.com
USAPillsrx.net
USAMedz.com
BluePills-Rx.com
Genericpharmacy.us
I-Kusuri.jp

The U.S. Food and Drug Administration (FDA) has announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation.

Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food. In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. Although the committees provide advice to the agency, their recommendations are not binding and FDA makes final decisions.

“FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Randall Lutter, Ph.D., FDA’s acting deputy commissioner for policy. “Today’s draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.”

FDA currently screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, FDA may grant a waiver when certain criteria are met, such as when the need for an individual’s expertise outweighs the potential for a conflict of interest.

This new guidance will enable the FDA to tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.

Financial interest means the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government’s action on a particular topic. Financial interests screened include, but are not limited to, stock ownership, related research and consulting arrangements.

GlaxoSmithKline is currently conducting clinical trials for Dutasteride, otherwise known as Avodart, as a treatment for male pattern baldness (MPB).

Dutasteride had been on track for FDA submission as a treatment for Androgenetic Alopecia, but in 2003 Glaxo pulled the plug on their Phase 3 hair loss trials, much to the dismay of many hair loss sufferers worldwide.

Internet rumors persisted for a long time about the reason why Glaxo pulled the plug, but with the release of Avodart as a treatment for Benign Prostatic Hyperplasia (BPH), the drug became readily available to anyone who could obtain a prescription.  Since then many men have taken the drug as a hair loss treatment with mixed results.   Some men have claimed to have excellent results, while others have complained about increased hair shedding.

The true efficacy will soon be known as it now appears something has changed at Glaxo and the trial is back on.    GlaxoSmithKline have set up a Phase 3 clinical study in Korea as part of the process to seek FDA approval for using Dutasteride as a treatment for male pattern hairloss.

A clinical study is being conducted in Korea and is enrolling men of the ages 18 - 49 to test the efficacy of Dutasteride in stimulating hair growth.
Men with a hair loss pattern classified as type IIIv, IV, or V on the modified Norwood-Hamilton classification are eligible to apply, but men who are a type IVa or Va are excluded from the trial.

Other exclusions from the trial include men who:

• Have global scalp hair thinning, including occipital areas
• Have scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
• Use hair colorants/hair dyes, or have the remaining traces of colorants in their hair.
• Have used finasteride (Propecia) or other 5 AR inhibitors within the 12 months prior to screening.
• Have previously use of dutasteride.
• Have used phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.

Or have used any of the following drugs during the 6 months prior to screening:

• Minoxidil (oral or topical)
• Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
• Topical estrogen, progesterone
• Tamoxifen
• Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)
• Anabolic steroids
• Lithium and phenothiazines

The expected total enrollment in this trial is 150 subjects and they will be using 0.5mg of Dutasteride taken daily.

It’s very unlikely that this is the only trial because typically drug trials are done at multiple locations to ensure accuracy.  It could either be a pilot trial or Glaxo could possibly be in the midst of setting up more trials at different centers.

COLLEGEVILLE, Pa., PRNewswire/ — Parents, pediatricians, and kids will be happy to learn that a remarkable non-toxic, insecticide-free treatment for head lice is closer to being available. Summers Laboratories has completed three phase III studies and is preparing for NDA submission of its patented lice asphyxiator to the U.S. Food and Drug Administration (FDA) for approval as a prescription head lice treatment.

In the recently completed phase III studies 251 primary subjects were treated with Summers’ Lice Asphyxiator. After the last of two treatments called for in the protocols, 230 subjects (91.6%) were treatment successes. These numbers were consistent with efficacy in phase II studies.

Summers Laboratories Lice Asphyxiator is an elegant, pleasant scented emulsion with the consistency of hair conditioner. Investigators reported Lice Asphyxiator was well tolerated and subjects had favorable comments on how their hair felt after treatment.

Summers’ Lice Asphyxiator consists of a simple mixture of common dermatological and cosmetic ingredients. Lice require oxygen to live and have developed sophisticated breathing apparatus called spiracles. They can close their spiracles and “hold their breath”, going into a sort of suspended animation for many hours. This is why other asphyxiating treatments like olive oil and even petroleum jelly yield only limited success. Summers Labs’ novel, patented treatment prevents lice from closing their spiracles, and then clogs the spiracles, quickly asphyxiating the lice.

Studies show that a 10- minute treatment is all that is required to asphyxiate lice with Lice Asphyxiator. A second treatment is performed in approximately a week to kill any lice that hatch from nits after the first treatment. In addition to having a pleasant scent, Lice Asphyxiator is easily rinsed after treatment. Subjects have reported that it left their hair feeling as if they have used a salon hair conditioner.

Summers is preparing to market Lice Asphyxiator primarily to pediatricians.

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug.

Reports show several consumers in the United States have sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation.

Therefore, the agency is reissuing its warning to consumers about the possible dangers of buying prescription drugs online. FDA urges consumers to review the FDA Web site for information before buying medication over the Internet.

FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia. FDA learned about these mislabeled and potentially dangerous products after their recipients complained to a U.S. pharmaceutical manufacturer.

The origin of these tablets is unknown but the packages were postmarked in Greece. Photographs of the tablets in question and the shipping packages can be seen at http://www.fda.gov/bbs/topics/news/photos/haloperidol.html. If the tablets received from an Internet seller resemble those in the photos and haloperidol was not specifically ordered, do not take these tablets. Instead, consumers should notify their health care provider and report the suspected products to FDA by submitting a product quality problem report at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

Taking medication that contains an active ingredient other than what was prescribed by a qualified health care professional is generally unsafe. FDA continuously warns U.S. consumers of the possible dangers of buying prescription drugs online and urges them to review the FDA Web site for additional information prior to making purchases of medication over the Internet (http://www.fda.gov/buyonline/).

The U.S. Food and Drug Administration (FDA) announced on Monday that it has cleared for marketing in the U.S. the TephaFLEX Absorbable Suture—the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology.

Recombinant DNA technology uses living organisms to create chemicals that may be more difficult to produce under standard industrial methods.

“The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology,” said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. “This approach could have broader applications for medical devices that use this novel manufacturing technology.”

FDA based its decision on the company’s laboratory and animal testing that examined chemical composition, biological safety and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner.

FDA reviewed safety and effectiveness information for the device under the de novo petition process. De novo petitions were added under the Food and Drug Administration Modernization Act of 1997 to find a way for novel but less risky products to get to market. As a result of its review, FDA determined that products of this type will be regulated as class II (moderate-risk) devices.

The device is contraindicated in patients allergic to the cells or the growth media used to produce the absorbable polymeric material.

Doctors use sutures in patients to hold soft tissue together while the tissue heals from a deep cut or surgical incision. Absorbable sutures are made of materials that break down in the body after a short period of time.

TephaFLEX Absorbable Suture is manufactured by Tepha, Inc., of Cambridge, Mass.

FDA’s regulation of all medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II) or high-risk (class III) categories. The FDA regulatory program for medical devices is comprehensive and includes requirements for registration and listing of products, premarket evaluation, high-quality production using good manufacturing practices and post-market reporting of adverse events.