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E-Articles - Hair Loss Drug Options - Why Only Two?
For a hair loss drug to get FDA approval is no mean accomplishment. Hair loss drugs or any medical drug or device cannot be put on the market in the USA without firs
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 getting specific approval from the Food and Drug Administration (FDA) government agency.
While some argue the process is so slow and exacting that many beneficial drugs
While some argue the process is so slow and exacting that many beneficial drugs
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
re kept off the market due to the investment and financial resources needed to go through the approval process, on the other hand, the fact a hair loss drug 'makes it' in i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
self makes it worthy of serious consideration.
A typical drug for example has to undergo over 60 clinical trials and is tested on around 5,000 patients as part of the proc
A typical drug for example has to undergo over 60 clinical trials and is tested on around 5,000 patients as part of the proc
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ss.
The First
On December 19, 1997, the FDA gave approval for the first pill to combat male pattern baldness to be marketed under prescription. It's name? Propecia
The First
On December 19, 1997, the FDA gave approval for the first pill to combat male pattern baldness to be marketed under prescription. It's name? Propecia
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Many years earlier, in 1988, another prescription hair loss drug, Rogaine, (also called Minoxidil due to the main ingredient) gained approval.
Some years later, on Febru
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
ry 9, 1996, the FDA followed an advisory committee's recommendation to change the status of Rogaine from prescription only to over the counter availability.
It is importan
It is importan
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
to state here that Propecia is only suitable for males. Women though are not left without a hair loss drug solution as Rogaine (Minoxidil) is available for both men and wo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
en.
A further note on Rogaine for women: Many start with the 2% form of Rogaine and observe the results. The 5% form is best used by men. Some women, when finding the 2% f
A further note on Rogaine for women: Many start with the 2% form of Rogaine and observe the results. The 5% form is best used by men. Some women, when finding the 2% f
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
rm doesn't work so well use the 5% form but there is a risk of unwanted facial hair as a side effect.
Hair Loss Drug Limitations
No hair loss drug is ideal. In the
Hair Loss Drug Limitations
No hair loss drug is ideal. In the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
case of Propecia, clinical trials revealed it is effective on the top of the head and the mid-scalp area, but there is no conclusive evidence it works on receding hair at t
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e temples.
It is necessary to take these hair loss drugs for some months before seeing any benefits. Perseverance is needed perhaps even beyond that.
Propecia, taken as a
It is necessary to take these hair loss drugs for some months before seeing any benefits. Perseverance is needed perhaps even beyond that.
Propecia, taken as a
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
pill, has an effect on hair loss by blocking the formation of DHT, the main enemy in the hair loss war.
On the other hand, Rogaine, a liquid applied directly to the scalp,
On the other hand, Rogaine, a liquid applied directly to the scalp,
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
stimulates the hair follicles to produce new hair.
Of course, drugs have side effects and these two hair loss drugs are no exception. Rogaine, in a few cases, may cause ir
Of course, drugs have side effects and these two hair loss drugs are no exception. Rogaine, in a few cases, may cause ir
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
itation, itching, and redness to the areas it is applied to.
With regard to Propecia, sexual potency was affected in a small number of men who used it during the clinical
With regard to Propecia, sexual potency was affected in a small number of men who used it during the clinical
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
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
rials.
Precautions
Before taking any kind of drug, it is important to consult with a medical practitioner, especially if an individual has other health problems. I
Precautions
Before taking any kind of drug, it is important to consult with a medical practitioner, especially if an individual has other health problems. I
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
the case of Propecia this is mandatory as it is only available on prescription.
With Rogaine, it is wise to check with a doctor if a person experiences side effects such
With Rogaine, it is wise to check with a doctor if a person experiences side effects such
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s chest pain, fainting or dizziness, heart palpitations or sudden weight gain.
In conclusion it can be see the FDA is there for the protection of the public, even i
In conclusion it can be see the FDA is there for the protection of the public, even i
.
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
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
it's approval process is long and drawn out. For these reasons, at the time of writing, there are only two hair loss drugs which have met the stringent requirements of the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
FDA approval process.
Check the resource box below for answers to frequently asked questions on Rogaine and Propecia as well as online resources for getting the best price
Check the resource box below for answers to frequently asked questions on Rogaine and Propecia as well as online resources for getting the best price
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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