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Recent reports have leaked out that Pfizer has been planning the release of an

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

over-the-counter spray version of their blockbuster prescription drug Viagra.

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

Examples of combination products may in

According to MSNBC.com, analysts say that, “it is highly unlikely that federal

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

regulators would ever give Pfizer Inc. approval to sell its erectile dysfunctio

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

medication Viagra over the counter because of safety risks associated with the

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

Combination pro

drug.”

Critics say that it would be illogical for Pfizer to seek approval for

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

an OTC version of Viagra because there is no chance that regulators would appr

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

ve the drug for sales simply because men who take nitrates for chest pain are a

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

t serious health risks when mixed with Viagra.

Jason Napodano an analyst at Za

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

cks Independent Research said, “You can’t trust patients to read the label.”

J

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

n LeCroy, an analyst with Natexis Bleichroeder Inc. told MSNBC.com, he didn’t t

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

Following aspects would a

hink the FDA would take a chance on letting a drug with such risks be sold with

dd to the challenges in developing combination products:

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

out a prescription, especially since it is a lifestyle product and not somethin

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

g that treats a disease.

The OTC version of the drug is said to be an attempt

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

or Pfizer to retain its dominance in the lucrative impotence drug market. In J

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

uly, Pfizer’s competitor, GlaxoSmithKline announced that it will be releasing a

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

Professional from academic institutions, pharmaceutical industries, health care indust

n over-the-counter impotence gel.

It looks like Pfizer may have to look somewh

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

re else to recoup its recent sales slump and keep up with its competition like

.

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

GlaxoSmithKline and Merck.

For more information on ordering from an online

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

Companies that provide selfless information through particip

target="_new" href="http://www.freebeeforeignpharmacy.com">foreign pharmacy

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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