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Genital warts, also known as condyloma, or condylomata acuminata, is a highly contagious sexually transmitted infection. It is spread during oral, genital, or anal sex with a

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

n infected partner. Genital warts are the most easily recognised sign of genital HPV infection.

Genital warts often occur in clusters and can be very tiny or can spread into

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

Examples of combination products may in

large masses in the genital or anal area. In women the warts occur on the outside and inside of the vagina, on the cervix, uterus or around the anus. While genital warts are

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

approximately as prevalent in men, the symptoms of the disease may be less obvious. When present, they usually are seen on the tip of the penis. They also may be found on th

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

e shaft of the penis, on the scrotum, or around the anus. Rarely, genital warts also can develop in the mouth or throat of a person who has had oral sex with an infected pers

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

Combination pro

on.

Genital warts often disappear even without treatment. In other cases, they eventually may develop a fleshy, small raised growth that looks like wadi. There is no way to

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

predict whether the warts will grow or disappear. Therefore, if you suspect you have genital warts, you should be examined and treated, if necessary.

Depending on factors su

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

ch as the size and location of the genital warts, a doctor will offer you one of several ways to treat them.

* Imiquimod, a topical immune response cream which you can apply

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

to the affected area
* A 20% podophyllin anti-mitotic solution, which you can apply to the affected area and later wash off
* A 0.5% podofilox solution, applied to

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

the affected area but shouldn’t be washed off
* A 5% 5-fluorouracil (5-FU) cream
* Trichloroacetic acid (TCA)
* Pulsed dye laser
* Liquid nitrogen cryosu

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

rgery

If you are pregnant, you should not use podophyllin or podofilox because they are absorbed by the skin and may cause birth defects in your baby. In addition, you s

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

Following aspects would a

hould not use 5-fluorouracil cream if you are trying to become pregnant or if there is a possibility that you could be pregnant.

If you have small warts, the doctor can remo

dd to the challenges in developing combination products:

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

ve them by freezing them, burning them or with laser treatment. Occasionally, the doctor will have to use surgery to remove large warts that have not responded to other treat

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

ment.

Some doctors use the antiviral drug interferon-alpha, which they inject directly into the warts, to treat warts that have returned after removal by traditional means.

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

The drug is expensive, however, and does not reduce the rate that the genital warts return.

Although treatments can get rid of the warts, they do not get rid of the HPV viru

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

s, so warts can recur after treatment. However, the body's immune system typically clears the virus anywhere from 6 months to a year. There is even some suggestion that effec

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

Professional from academic institutions, pharmaceutical industries, health care indust

tive treatment of the wart may aid the body's immune response.

The virus that causes genital warts is spread by skin-skin contact. Condoms do not adequately protect against

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

genital warts, because the infected spot may not be covered by a condom. The only reliable prevention is to have no skin contact with potentially infected tissue.

Gardasil,

.

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

an effective HPV vaccine, is currently undergoing a phase III clinical trial and appears nearly 100% effective against the most common types.

Disclaimer - T

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

Companies that provide selfless information through particip

he information presented here should not be interpreted as or substituted for medical advice. Please talk to a qualified professional for more information about Genital Warts

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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