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Feline leukemia virus (FeLV) remains one of the most important causes of disease and death in ca

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

ts. It causes a variety of malignancies, but persistent infection can also cause severe immunosu

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

Examples of combination products may in

pression and profound anemia. The virus is present worldwide. Prevention and Control: A test an

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

removal program to rid catteries and multicat households of FeLV can be extremely effective if

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

hese guidelines are carefully followed:

1) All cats should be tested for FeLV viremia (IFA is b

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

Combination pro

st).
2) All viremic cats should be removed.
3) All dishes, litterpans, and bedding s

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

ould be disinfected.
4) All movement of cats in and out of the cattery should be prevented

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

.
5) All cats should be retested after 12 weeks to detect cats that may have been incubati

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

g the virus at the time of the first test.
6) The quarantine can be lifted when all cats h

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

ve tested negative on two consecutive occasions, 12 weeks apart.
7) All cats should be tes

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

ed and quarantined before introduction to the cattery. Ideally, two tests 12 wk apart should be

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

Following aspects would a

one.
8) Breeding should be only to cats known to be FeLV-negative, and cats should be intr

dd to the challenges in developing combination products:

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

duced only from FeLV-negative colonies.

FeLV vaccines are intended to protect cats against FeLV

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

infection or, at least, to prevent persistent viremia. Types of vaccines include killed whole vi

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

rus, subunit, and genetically engineered. Vaccines may vary in protective effect, and manufactur

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

rs' claims and independent comparative studies should be carefully noted. The following guidelin

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

Professional from academic institutions, pharmaceutical industries, health care indust

s for vaccine use have been recommended:
1) Only healthy, afebrile (no fevers) cats should

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

be vaccinated.
2) Cats from a high-risk or unknown background should be tested for FeLV be

.

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

ore vaccination.
3) All cats at risk of exposure to FeLV should be vaccinated.
4) Po

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

Companies that provide selfless information through particip

itive and Negative cats should be kept separated, even if the negative cats have been vaccinated

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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