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Harley’s continuing commitment to produce true-blooded American motorcycles has produced several models for 2007.

Starting off

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

with the Harley-Davidson Sportster.

The Harley-Davidson Sportster has 8 models. The Sportster is the least expensive among the

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

Examples of combination products may in

Harley-Davidson motorcycles. The XL 883 Sportster is the cheapest starting at $6,595 – 7,990. The lower version, the XL 884 Spor

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

tster Low is priced between $6,995 – 8,390. Next is the XL 883 Custom which is priced between $7,795 – 9,555. The fourth Sportst

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

er is the XL 883 R. This is one exciting Harley-Davidson model with price from $7,795 – 9,090. The bigger XL1200 Custom is price

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

Combination pro

d much higher are 9,695 – $11,470. The XL 1200 Roadster on the other hand has a tag price of $8,695 – 10,090, The lower version

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

of the XL 1200 Roadster, the XL 1200 Low is sold at $9,495 – 11,100. And finally, the model that celebrates that 50 years of con

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

quering the road, the XL 50 is priced at $9,795 10,830.

A much higher model, the Dyna, has 5 versions. First is the FDX Super G

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

lide with tag price ranging from $12,395 – 14,785. The FXDC is priced at $14,645 – 16,135. The mid-range Dya, the FXDB is priced

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

a from $13,595 – 14,785. Next on the list is the FXDL Low Rider which is sold at $15,795 - 17,765. Finally, the FXDWG Wide Glid

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

is sold at $16,795 – 18,765.

The mid-range Softtail is offered with 8 model-lineup. It starts with the FXST Standard with a pr

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

Following aspects would a

ice ranges from $14,995 – 16,810. The next one is the FXSTB Night Train at $15,895 – 19,385. The FXSTC Custom is priced between

dd to the challenges in developing combination products:

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

$16,895 to 18,485. The FXSTD Duece is priced at $17,345 – 18,865. The Fat Boy is between $17,095 to 18,980. The FLSTN Deluxe has

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

a tag price of $17,345 – 19,315. The FLSTSC Springer is priced at $17,545 – 19,515. The Classic version ot the FLSTC is priced

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

at $17,820 – 20,015.

The other Harley-Davidson models are as follows:

VRSC

VRSC V-Rod $16,495 – 18,775
VRSCD Night Ro

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

d $14,995 – 19,050
VRSCDX Night Rod Special $16,495 – 17,210
VRSCX $19,995 – 21,205
VRSCR Street Rod $1

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

Professional from academic institutions, pharmaceutical industries, health care indust

5,495 – 16,495

Touring

Touring FLHR Road King $17,345 – 19,265
Touring FLHRS Road King Custom $17,525 – 19,075
To

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

uring FLHRC Road King Classic $17,695 – 19,565
Touring FLH Street Glide $18,295 – 19,935
Touring FLTR Road Glide $

.

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

17,695 – 19,335
Touring FLHT Electra Glide Standard $19,095 – 17,935
Touring FLHTC Electra Glide Classic $18,095 – 20,

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

Companies that provide selfless information through particip

205
Touring FLHTCU Ultra Classic Electra Glide $20,185 – 22,545

Prices are based from the Harley-Davidson official website

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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