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. They are as
safe and effective as brand-name drugs.
An added advantage with generic drugs is that they
are less expensive because generic manufacturers don't
have the investment costs of the developer of a new
drug. New drugs are developed under patent protection.
The patent protects the investment-including research,
development, marketing, and promotion-by giving the
company the sole right to sell the drug while it is
in effect. As patents near expiration, manufacturers
can apply to the FDA
to sell generic versions. Because those manufacturers
don't have the same development costs, they can sell
their product at substantial discounts. Also, once
generic drugs are approved, there is greater competition,
which keeps the price down. Today, almost half of
all prescriptions are filled with generic drugs.
FDA ensures that generic drug is safe and effective. All generic drugs are put through a rigorous, multi-step approval process. From quality and performance to manufacturing and labeling, everything must meet FDA's high standards.
According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.
FDA approved generic drugs have to meet the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
- Contain the same active ingredients as the innovator drug (inactive ingredients may vary)
- Be identical in strength, dosage form, and route of administration
- Have the same use indications
- Be bioequivalent meet the same batch requirements for identity, strength, purity, and quality
- Be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
You can get more information on generic drugs by clicking the link below.
http://www.fda.gov/cder/consumerinfo/generics_q%26a.htm
Generic Cialis
Generic Cialis is also available as Apcalis, Regalis.
Product description
Apcalis is a light yellow, almond-shaped
film-coated tablet. It is available in blister packs
containing 2 tablets with 4 tablets in box. Like Cialis
, it is a treatment for men with erectile dysfunction.
It also belongs to a group of medicines called phosphodiesterase
type 5 inhibitors. Following sexual stimulation it
works by helping the blood vessels in the penis to
relax, allowing the flow of blood into the penis,
resulting an improved erectile
function.
