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Depression is more than a gloomy and terrifying disorder; it can be lethal. Therefore, anyone with moderate to severe depression requires vigorous treatmen

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

t immediately. There are many different depression medications. These same antidepressants can also help treat panic disorder, other anxiety disorders, eat

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

Examples of combination products may in

ing disorders, and attention deficit disorder.

Depression has been linked to a shortage of any one of four different neurotransmitters: serotonin, norepin

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

ephrine, dopamine or epinephrine. Depression medications are designed to correct neurotransmitter shortages by increasing the body’s supply of one or more

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

of these important brain chemicals.

There are three main classes of depression medications:

-Tricyclic Antidepressants (TCAs) increase brain norepinephri

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

Combination pro

ne levels. From the 1960s through the 1980s, TCAs were the first line treatment for major depression in the U.S. – Today however, TCAs are generally used a

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

s the second or third line therapies. Side effects from this depression medication include dry mouth, sleepiness, idiopathic pulmonary fibrosis (scarring o

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

r thickening of deep lung tissue), weight gain, blurred vision, constipation, fast or irregular heartbeat, bladder weakness, tremors, and dizziness. Brand

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

name drugs in this class are Tofranil, Desipramine, Doxepin, and Elavil.

- Monoamine Oxidase Inhibitors (MAO) Is an enzyme that breaks down three importan

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

t neurotransmitters. Norepinephrine, dopamine, and serotonin. MAOIs have been largely replaced by SSRIs, although many patients with major depression who d

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

not respond to TCAs improve with MAOIs. Depressed patients with specific symptoms like sleeping too much, over-eating for long periods of time, rejection

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

Following aspects would a

sensitivity, and panic attacks, may get the best results with MAOIs. MAOIs are also effective treatments for panic disorder and bipolar depression. Side ef

dd to the challenges in developing combination products:

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

fects from this depression medication includes tremors, edema, dizziness, constipation, sleepiness, dry mouth, blurred vision, weight gain, sexual dysfunct

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

ion, increased blood pressure, and fast or irregular heartbeat. Brand name drugs in this class are, Parnate, Nardil, and Marphan.

- Selective Serotonin Re

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

-uptake Inhibitors (SSRIs) are the newest of the three main classes of depression medications. They prevent the reabsorption of serotonin from the synapse

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

where neighboring brain cells communicate. SSRIs are the current depression medication of choice because of their limited side effects, although they may c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ause insomnia, agitation, headache, nausea, and diarrhea. Brand name drugs in this class are, Prozac, Zoloft, Paxil, Celexa, and Lexapro.

It is easy to fa

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

ll into the trap of thinking that taking a pill is the easy way out. While a medication may take away symptoms of a disease – it does not cure the problem,

.

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 often creates a completely new array of side effects. It is important to discover the root of the problem and treat it in a way that can bring lasting

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

Companies that provide selfless information through particip

relief. In attacking depression, lifestyle measures should be your first line of defense. Herbs or depression medications should be a last line of defense

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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