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Concerta, a brand name for the drug Methylphenidate, is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hypera

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ctivity Disorder, ADHD in children and adults.

Other brand names include Ritalin, Ritalina, Metadate, Methylin and Rubifen. Concerta is also one

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

f the primary drugs used to treat symptoms of traumatic brain injury and the daytime drowsiness symptoms of narcolepsy and chronic fatigue syndrom

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

.

This drug and was initially prescribed as a treatment for depression, chronic fatigue, and narcolepsy, among other ailments. Beginning in the 1

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

60s, it was used to treat children with ADHD, known at the time as hyperactivity or minimal brain dysfunction.

Today Concerta is a popular medica

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ion prescribed to treat ADHD around the world. According to most estimates, more than 75 percent of prescriptions containing Methylphenidate are w

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

itten for children. Boys being about four times as likely to take Concerta as girls.

Concerta is a central nervous system stimulant. It has a "ca

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ming" effect on many children who have ADHD, reducing impulsive behavior and the tendency to "act out", and helps them concentrate on schoolwork a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

d other tasks. Adults who have ADHD often find that Concerta increases their ability to focus on tasks and organize their lives.

Concerta has bee

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

found to have a lower incidence of side-effects compared to dextroamphetamine, a less commonly prescribed medication. When prescribed at the corr

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ct dosage, Concerta is usually well-tolerated by patients.

Some consider the treatment of children with stimulant medication to be controversial

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ince the number of children taking them has increased dramatically over the years. However, criticism that Concerta and other brand name drugs tha

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

contain methylphenidate are over prescribed may be unfounded. The incidence of ADHD is believed to be between three and five percent of the popul

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

tion, while the number of children in America taking Concerta and Ritalin is estimated at one to two percent.

Some have argued that prescription

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

f stimulant medications sets children up for future addictions. However, recent research suggests that boys with ADHD who are treated with stimula

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ts like Concerta are actually less likely to abuse drugs including alcohol later in life.

As long-term use of Concerta and other drugs that conta

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n methylphenidate was relatively uncommon before the 1990s. The long-term neurological effects were not well researched. In a 2005 study, no "clin

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

cally significant" effects on growth, vital signs, tics, or laboratory tests including urinalysis, hematology/complete blood counts, electrolytes,

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

and liver function tests were observed after 2 years of treatment.

Disclaimer: The information presented here should not be inte

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

preted as medical advice. Please seek professional medical advice regarding the use of Concerta or any other medication containing Methylphenidate

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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