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.