For as long as there has been baldness, it seems, there have been efforts to cure it: oils and creams, toupees and transplants, not to mention what hair stylists gingerly term ”the comb-over.” But as much as some men may have wanted one, there has never been a baldness pill — until now.

The Food and Drug Administration announced today that it had given Merck & Company, the maker of crucial treatments for heart disease, osteoporosis and AIDS, permission to sell a tiny tan octagonal tablet that, experiments show, either promoted the growth of hair or at least stopped hair loss in 83 percent of men who took it.

There are, however, some drawbacks: The pill, which will be marketed as a prescription medicine under the brand name Propecia, can cause birth defects and so is not approved for women. It is useful only for the genetic condition known as male pattern baldness. It must be taken once a day, every day, for the rest of a bald man’s life. And it carries a slight risk of impotence, lasting as long as it is taken.

”This is not a panacea,” said Dr. E. William Frank, a dermatologist at Beth Israel Deaconess Medical Center in Boston who has been following the progress of the drug during testing. ”It’s not going to grow hair on the pate of every man who takes it. But the clinical studies which have been done so far are promising.”

Critics say the idea of a prescription drug for baldness is frivolous, and complain that no long-term studies have been conducted on the drug.

”It is a cosmetic issue,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, an advocacy organization in Washington. ”What is the risk that we are trading off for a cosmetic benefit?”

And John T. Capps 3d, founder of Bald-Headed Men of America, a support group for bald men, said no right-thinking bald man would even consider a pill.

”We believe that skin is in,” Mr. Capps said.

Under this process, the generic manufacturer uses the safety and efficacy data supplied by the brand company, and must only prove to the FDA that its generic product is equivalent to the branded product. The FDA does not require the generic company to conduct separate and complete clinical studies for safety and efficacy because the brand drug has been used safely for many years.

In order to receive FDA approval, a generic must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, same amount of drug absorbed over the same time, and same clinical effect as the brand product.

The FDA also requires that a generic company’s manufacturing methods conform to current good manufacturing practices (cGMP), as defined in the U.S. Code of Federal Regulations. The company must follow the cGMPs in all phases of the manufacturing process, and continually monitor compliance and measure quality control.

Once all FDA requirements are met, a generic drug is given approval and typically dispensed under the chemical name of the active ingredient, although generic manufacturers may also choose to market specific generic drugs under a unique trade-name. Occasionally generics may be a slightly different size, shape or color than their brand counterpart, but these cosmetic differences have no impact on the safety or effectiveness of a generic prescription drug.

For nearly two decades, America’s generic pharmaceutical industry has been developing, manufacturing and marketing bioequivalent generic versions of brand prescription drugs. These generic products have been used by millions of American consumers, and offer the same safety and effectiveness as their brand counterparts.

In order to be deemed therapeutically equivalent to brand products, generic drugs must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, and same amount of drug absorbed over the same time as the equivalent brand product. Generics are also required to meet the same stringent government standards for strength, purity and potency as the brand version.

The Food and Drug Administration (FDA) has repeatedly affirmed that the generic approval process is as rigorous and thorough as the process by which brand drugs are approved. When a generic drug receives FDA approval, research and clinical experience indicates that the generic drug is not only bioequivalent but also clinically equal to and as safe and effective as the brand name drug it is a copy of.

In order to market a generic equivalent to a brand pharmaceutical company’s drug product (once the market exclusivity on the innovator’s product has expired), a generic pharmaceutical company uses the Abbreviated New Drug Application (ANDA) process of the FDA.

On 19 th August, 2003 , The Food and Drug Administration (FDA) approved Levitra ( (Vardenafil Hydrochloride ), an oral medication to treat erectile dysfunction (ED, or impotence) in men. This is the second oral product approved for this condition.

Levitra is different than currently approved product for ED like Viagra because it works faster and also stays in the body longer.

Manufacturer:
Levitra is manufactured by Bayer and GlaxoSmithKline.

Mode of Action :
Levitra acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Are generic drugs as safe as brand-name drugs?

Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

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.

Emboldened by favorable court rulings and the need to gain an early foothold in the market, generic drug developers are increasingly challenging lucrative drug patents.

In many cases those challenges have been coming in the form of at-risk launches, where a generic version of a patented drug is sold before the patent expires.

Heavyweights including Teva Pharmaceutical Industries Ltd., Barr Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. have been growing bolder when it comes to this strategy, as the risk-reward equation seems to have shifted to their favor.

“I think they’ve just gotten a lot smarter as an industry,” said WR Hambrecht analyst Andrew S. Forman. “Generics have the sympathy, pricing advantage and generally have facts on their side; there’s been settlements, but no losses.”

Often, he said, pharmaceutical companies will try to gain patent extensions to stave off generic competition. With more insurers and Medicare pushing members to generic options because of the price difference, the market seems to have swayed. Generic drug developers now claim more than two-thirds of all prescriptions, up from less than half 10 years ago.

The most recent salvo came from Teva, the largest generic drug developer in the world. The Israel-based company had challenged Wyeth’s patent on the blockbuster heartburn drug Protonix. That patent isn’t due to expire for three more years, but in December, Teva launched its generic version over the course of several days, before ceasing shipments as part of a deal.

Protonix sales reached $1.9 billion in 2007. Drugstore.com currently lists generic Protonix at a 7.7 percent discount to the branded version. A similar discount currently exists for Lotrel, a blood pressure drug made by Novartis, for which Teva enjoys market exclusivity with a generic.

Other disputes involve Forest Laboratories Inc. and generic drug developers Teva and Barr over the Alzheimer’s disease treatment Namenda. Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. are suing Impax Laboratories over plans to make a version of the pain reliever Opana ER.

Several pharmaceuticals companies, including Forest and Wyeth, declined comment on the ongoing patent challenges.

“There are just more Paragraph IV (patent dispute) challengers than years ago,” said Mike Dzwonczyk, a patent attorney at Sughrue Mion PLLC. “The likelihood of sharing market space is much higher now than it ever used to be.”

While generic companies run the risk of paying triple-damages if they conduct an at-risk launch and then lose the patent dispute, several recent court cases have gone in favor of generics, he said. It has become harder for pharma to prove a company willfully infringed a patent, for example, lessening the risk of triple damages.

Also, the downside risk to losing a case has become smaller for large companies like Teva, which can often offset any future losses with big sales gains early on.

Most prescription drugs placed on the market are given trade names (also called proprietary, brand, or specialty names) to distinguish them as being produced and marketed exclusively by a particular manufacturer. In the United States, these names are usually registered as trademarks with the Patent Office; this gives the registrant certain legal rights with respect to the use of the name. A trade name may be registered for a product containing a single active ingredient, with or without additives, or for one containing two or more active ingredients.

A drug marketed by several companies may have several trade names. A drug manufactured in one country and marketed in many countries may have different trade names in each country.

Throughout this book, generic (nonproprietary) names have been used whenever possible. However, because trade names are used commonly and may be more readily recognized, the generic drugs mentioned in this book are listed below in alphabetic order along with many of their trade names. A second table follows, listing the trade names in alphabetic order along with their generic name.

With few exceptions, the trade names in these tables are limited to those marketed in the United States. These tables are by no means all-inclusive, and no effort has been made to list every trade name in current use for each drug. The inclusion of a drug in these tables does not indicate approval of a drug’s use, nor does it imply that a drug is effective or safe. Many drugs are marketed almost exclusively under their generic name. Including a trade name of such a drug in these tables does not indicate an endorsement or preference for the trade name version over the generic version.

Whether it is best to use a trade or a generic version of a drug may be a complex decision. It is best to discuss such matters with a doctor or pharmacist.

No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.