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."

 

Facts about GenericDrugs

"Today, nearly 8 in 10 prescriptions filled in the United States are for generic drugs."

 

What's Involved in Reviewing andApproving Generic Drug Applications

"It takes FDA time to review the complex information needed to demonstrate that a given generic drug can be substituted for the brand-name drug that it copies, and that time also depends on the complexity of the drug product and the completeness of the application."

 

The Generic Drug Approval Process

"FDA requires a generic drug company produce enough data to demonstrate it can make a drug that can be appropriately substituted for its brand-name counterpart. The challenge to the generic drug maker is to prove to FDA that the generic version is substitutable with a brand-name drug that has been shown to be safe and effective. FDA’s challenge is to carefully review that data to ensure it proves the same thing. Let’s look at how both do their job."

 

Generic Drugs: Questions and Answers

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

"Are generic drugs as effective as brand-name drugs?"

 

Generic Oncology Drugs: are they all safe?

"Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist."

 

The role of generic medicines and biosimilars in oncology in low-income countries

"Cancer cases are rising in developing countries which are already grappling with high levels of infectious diseases including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB) and malaria. The United Nations (UN) including the World Health Organisation (WHO) have called on member states to establish strategies to deal with the increasing burden of non-communicable diseases, including cancer, in developing countries."

 

Safety concerns linger for generic oncology drugs in developing countries

"After analyzing safety data, [researchers] found that generic cancer drugs are generally safe in countries with rigorous regulatory programs similar to the FDA in the United States. However, in countries with less rigorous regulation, such as India, Iraq and Colombia, safety is far from certain…"

 

Ending the Shortage of Generic Oncology Drugs

"We have three patients on the upcoming schedule who need cisplatin. I just tried to order this from the distributor and none is available.' Once again an already busy clinic was faced with the recurring issue of “drug triage.” How much do we have on the shelf? Can anyone’s treatment safely be delayed? Can we send anyone to the hospital for treatment if they have some in stock?....Nationally, the number of drug shortages has tripled since 2005."

 

Generic Oncology Drug Shortages

"The origins of drug shortages are complex, as a confluence of factors is involved.1 The most frequently cited causes of drug shortages are manufacturing problems, raw material shortages, regulatory issues, and the lack of incentive for companies to manufacture or sell generic products. The generic products listed as being in short supply range from antibiotics and antihypertensive agents to common vitamin products."

 

Current Trends in Chronic Pain Management

"According to the American Chronic Pain Association, a simple definition of chronic pain is'pain that continues when it should not.' Without knowing or being able to treat the underlying cause, health-care professionals must turn to other methods of treating this pain in order to provide some level of relief to their patients." Eight Common Worries about Chronic Pain Medications "Many people who take chronic pain medication have concerns about their painkillers, though they don't always talk about them. Here are the most common pain medication concerns, and what you can do about them."

 

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