Generic Drugs: Questions and Answers


What are generic drugs?

A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. 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.

Generic vs Brand: Same Quality and Performance

Is there a generic equivalent for my brand-name drug?

To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling.

You can also search for generic equivalents by using the “Electronic Orange Book.” Search by proprietary “brand” name,” then search again by using the active ingredient name. If other manufacturers are listed besides the “brand name” manufacturer when searching by the “active ingredient,” they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the “Orange Book,” you should also consult the most recent monthly approvals for “First Generics“.

Are generic drugs as effective as brand-name drugs?

Yes. 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 and the way it should be used.

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

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

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; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

How are generic drugs approved?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. 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.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met 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.

Source:www.fda.gov

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Generic Drugs: Questions and Answers


What are generic drugs?

A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. 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.

Generic vs Brand: Same Quality and Performance

Is there a generic equivalent for my brand-name drug?

To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling.

You can also search for generic equivalents by using the “Electronic Orange Book.” Search by proprietary “brand” name,” then search again by using the active ingredient name. If other manufacturers are listed besides the “brand name” manufacturer when searching by the “active ingredient,” they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the “Orange Book,” you should also consult the most recent monthly approvals for “First Generics“.

Are generic drugs as effective as brand-name drugs?

Yes. 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 and the way it should be used.

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

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.

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; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

How are generic drugs approved?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. 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.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962.

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met 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.

Source:www.fda.gov

The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk


Milk and milk products provide a wealth of nutrition benefits. But raw milk can harbor dangerous microorganisms that can pose serious health risks to you and your family. According to an analysis by the Centers for Disease Control and Prevention (CDC), between 1993 and 2006 more than 1500 people in the United States became sick from drinking raw milk or eating cheese made from raw milk. In addition, CDC reported that unpasteurized milk is 150 times more likely to cause foodborne illness and results in 13 times more hospitalizations than illnesses involving pasteurized dairy products.

cows and a glass of milk

Raw milk is milk from cows, sheep, or goats that has not been pasteurized to kill harmful bacteria. This raw, unpasteurized milk can carry dangerous bacteria such as Salmonella, E. coli, and Listeria, which are responsible for causing numerous foodborne illnesses.

These harmful bacteria can seriously affect the health of anyone who drinks raw milk, or eats foods made from raw milk. However, the bacteria in raw milk can be especially dangerous to people with weakened immune systems, older adults, pregnant women, and children. In fact, the CDC analysis found that foodborne illness from raw milk especially affected children and teenagers.

“Pasteurized Milk” Explained

Pasteurization is a process that kills harmful bacteria by heating milk to a specific temperature for a set period of time. First developed by Louis Pasteur in 1864, pasteurization kills harmful organisms responsible for such diseases as listeriosis, typhoid fever, tuberculosis, diphtheria, and brucellosis.

Research shows no meaningful difference in the nutritional values of pasteurized and unpasteurized milk. Pasteurized milk contains low levels of the type of nonpathogenic bacteria that can cause food spoilage, so storing your pasteurized milk in the refrigerator is still important.

Raw Milk & Pasteurization: Debunking Milk Myths

While pasteurization has helped provide safe, nutrient-rich milk and cheese for over 120 years, some people continue to believe that pasteurization harms milk and that raw milk is a safe healthier alternative.

Here are some common myths and proven facts about milk and pasteurization:

  • Pasteurizing milk DOES NOT cause lactose intolerance and allergic reactions. Both raw milk and pasteurized milk can cause allergic reactions in people sensitive to milk proteins.
  • Raw milk DOES NOT kill dangerous pathogens by itself.
  • Pasteurization DOES NOT reduce milk’s nutritional value.
  • Pasteurization DOES NOT mean that it is safe to leave milk out of the refrigerator for extended time, particularly after it has been opened.
  • Pasteurization DOES kill harmful bacteria.
  • Pasteurization DOES save lives.

Raw Milk and Serious Illness

Symptoms and Advice

Symptoms of foodborne illness include:

  • Vomiting, diarrhea, and abdominal pain
  • Flulike symptoms such as fever, headache, and body ache

While most healthy people will recover from an illness caused by harmful bacteria in raw milk – or in foods made with raw milk – within a short period of time, some can develop symptoms that are chronic, severe, or even life-threatening.

If you or someone you know becomes ill after consuming raw milk or products made from raw milk – or, if you are pregnant and think you could have consumed contaminated raw milk or cheese – see a doctor or healthcare provider immediately.

The Dangers of Listeria and Pregnancy

pregnant womanPregnant women run a serious risk of becoming ill from the bacteria Listeria which can cause miscarriage, fetal death or illness or death of a newborn. If you are pregnant, consuming raw milk – or foods made from raw milk, such as Mexican-style cheese like Queso Blanco or Queso Fresco – can harm your baby even if you don’t feel sick.

Protect Your Family with Wise Food Choices

Most milk and milk products sold commercially in the United States contain pasteurized milk or cream, or the products have been produced in a manner that kills any dangerous bacteria that may be present. But unpasteurized milk and products made from unpasteurized milk are sold and may be harmful to your health. To avoid getting sick from the dangerous bacteria found in raw milk, you should choose your milk and milk products carefully. Consider these guidelines:/p>

Okay to Eat

  • Pasteurized milk or cream
  • Hard cheeses such as cheddar, and extra hard grating cheeses such as Parmesan
  • Soft cheeses, such as Brie, Camembert, blue-veined cheeses,Queso Fresco cheese and Mexican-style soft cheeses such as Queso Fresco, Panela, Asadero, and Queso Blanco made from pasteurized milk
  • Processed cheeses
  • Cream, cottage, and Ricotta cheese made from pasteurized milk
  • Yogurt made from pasteurized milk
  • Pudding made from pasteurized milk
  • Ice cream or frozen yogurt made from pasteurized milk

Unsafe to Eat

  • Unpasteurized milk or cream
  • Soft cheeses, such as Brie and Camembert, and Mexican-style soft cheeses such as Queso Fresco, Panela, Asadero, and Queso Blanco made from unpasteurized milk
  • Yogurt made from unpasteurized milk
  • Pudding made from unpasteurized milk
  • Ice cream or frozen yogurt made from unpasteurized milk

When in Doubt – Ask!

Taking a few moments to make sure milk is pasteurized – or that a product isn’t made from raw milk – can protect you or your loved ones from serious illness.

  • Read the label. Safe milk will have the word “pasteurized” on the label. If the word “pasteurized” does not appear on a product’s label, it may contain raw milk.
  • Don’t hesitate to ask your grocer or store clerk whether milk or cream has been pasteurized, especially milk or milk products sold in refrigerated cases at grocery or health food stores.
  • Don’t buy milk or milk products at farm stands or farmers’ markets unless you can confirm that it has been pasteurized.

Is Your Homemade Ice Cream Safe?

Each year, homemade ice cream causes serious outbreaks of infection from Salmonella. The ingredient responsible? Raw or undercooked eggs. If you choose to make ice cream at home, use a pasteurized egg product, egg substitute, or pasteurized shell eggs in place of the raw eggs in your favorite recipe. There are also numerous egg-free ice cream recipes available.

Source:www.fda.gov