Doramectin    "MUMs"

 

 

 

8-2-04  Doramectin 

Journal of Veterinary Pharmacology & Therapeutics
Volume 27 Issue 3 Page 187  - June 2004
doi:10.1111/j.1365-2885.2004.00556.x 
 
 
Short Communication
The pharmacokinetics of topical doramectin in llamas (Lama glama) and
alpacas (Lama pacos) 
R. P. Hunter*, R. Isaza , , D. E. Koch*, C. C. Dodd  & M. A. Goatley* 


This study provides pharmacokinetic data in two different species of New
World camelids following a single 0.5 mg/kg topical administration of
doramectin.  It appears that the extent of absorption, as evaluated by C max
and AUC, is much less than that reported for cattle. The formulation used in
this study was optimized for cattle. It is likely that differences in dermal
physiology and anatomy between New World camelids and cattle effected the
extent of topical absorption for doramectin.

These findings indicate that New World camelids may need to be treated more
frequently or with a higher dose of topical doramectin than that approved in
the US for cattle. However, this would depend on the sensitivity of a
particular parasite to doramectin. The duration of detectable plasma
concentrations is important when comparing the plasma concentrations between
llamas and alpacas. The last quantifiable plasma concentration was on day 30
for alpacas and on day 40 for llamas. This would appear to indicate, even
with the lack of significant differences in pharmacokinetic parameters, that
these two species of camelid may need different dosage regimens in order to
produce similar efficacy.

The authors observed limited, short-term discoloration (<1 week) of the wool
following application of doramectin in both species. This discoloration was
less in severity and for a shorter duration than observed with moxidectin
(Hunter et al., 2004). Efficacy trials are now needed, along with
pharmacokinetic studies, involving alternate routes of administrations based
on the approved cattle injectable formulation in these two species of New
World camelids.

This study was funded as part of Morris Animal Foundation Grant # D01LA-10.

 

 

 

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8-4-04

Minor Use and Minor Species Animal Health Act (MUMS).


The minor use minor species animal health act of 2004 (MUMS) was signed into
law by President Bush, Monday, August 2, 2004.


This is truly a great day for livestock agriculture!


David E Anderson, DVM, MS, DACVS
Ohio State University
----------------------------

 

7-21-04

Minor Use and Minor Species Animal Health Act (MUMS)

 

Dear MUMS Coalition:

Congratulations! As many of you have heard, the MUMS legislation was passed
by the House of Representatives yesterday (June 20, 2004) evening.  The
legislation now goes to President Bush for his signature although the path
is not direct.  The legislation must first be enrolled and put in a form
suitable for a presidential signature.  This then goes to Executive Records
to remain in line for action for up to 10 days.  Since there have been a
number of bills passed in the last several days it may take some time before
we know when the signature occurs but we will certainly let you know.

Our MUMS Coalition has worked well together and we should feel good about
what we have accomplished.  Working together, particularly with the FDA-CVM
as technical advisors and our key congressional sponsors (Senator Sessions
and Congressman Pickering), we have been able to amend the Federal Food,
Drug, and Cosmetic Act in a way never before accomplished.  Our effort was
to provide incentives for pharmaceutical companies to devote resources for
drug development for minor animal species and minor uses in major species.
There is good reason to believe we have succeeded.  While the MUMS
legislation created several new incentives most prominent are the
conditional drug approval and the index of legally marketed unapproved drugs
(drug index).  Each has certain advantages and limitations.
Additional incentives include safeguards that have been created to protect
existing New Animal Drug Approvals (NADA) from unwarranted scrutiny should a
pharmaceutical company attempt to supplement the existing approval to
address minor animal species or minor uses.  The legislation also creates a
new approach to facilitating drug development through a designated new
animal drug classification system.  Designated new animal drugs are eligible
for grants for safety and efficacy testing, and for manufacturing process
development. A new Office of Minor Use and Minor Animal Species Drug
Development is created whose mission is to issue the grants, determine
eligibility for listing on the drug index and for serving as a liaison
amongst government agencies to improve opportunity for drug approvals. Time
will ultimately determine how successful these incentives are but we should
be optimistic.

While the legislation has finally been passed, our task is by no means
finished.  The FDA will need to institute a rule making process that will
govern various aspects of the MUMS legislation.  For example, just how the
drug index process will work will need to be worked out.  The rule making
process may involve many of us in the effort.  Additionally, the tax
exemptions originally proposed by the FDA-CVM were dropped from the MUMS
legislation in order to expedite passage in congress. We need to determine
if it would be advantageous to pursue those provisions.  Finally, we may
need to be involved in securing appropriations for FDA-CVM to completely
operate the grant and liaison program.

Once again, congratulations and thank you for your participation in this
effort.

Dr. Randy MacMillan
Chairman, MUMS Coalition
208-543-3456


____________________

Press release from Wed. PM:


FDA Commends Passage Bill Providing Incentives for Animal Drug Development
[edited] Southwest Nebraska News July 21, 2004

FDA commends the passage by the House of Representatives of S. 741, a bill
that includes the Food Allergen Labeling and Consumer Protection Act, as
well as the Minor Use and Minor Species Animal Health Act (MUMS). Energy and
Commerce Committee Chairman Joe Barton and Ranking Member John D. Dingell
were instrumental in moving this bipartisan legislation forward in the
House.  House approval of the Senate-passed bill represents final
Congressional action that clears the way for enactment of this important
legislation that will help consumers identify foods that can cause severe
allergic reactions and separately that will help create new incentives to
develop and seek approval for treatments of diseases in animals, including
zoo animals, exotic species and pets. The Agency applauds the dedication and
leadership of the bill's sponsors in the Senate, including Health,
Education, Labor, and Pensions Committee Chairman Judd Gregg and Ranking
Member Edward Kennedy as well as Senators Jeff Sessions and Jeff Bingaman.

The Minor Use and Minor Species Animal Health Act is intended to increase
the availability of new therapies for animals, including zoo animals and
some pets for which treatments for many ailments currently do not exist or
are not available. This legislation will establish two new ways to lawfully
market new animal drugs while safeguarding public health and make available
incentives, such as grants, for certain new animal drugs for minor uses and
minor species.

"Increasing the availability of safe and effective drugs to treat minor
species and other species with unusual conditions promotes animal welfare
and provides additional public health protection from animal diseases that
can be transferred to humans, said Dr. Crawford "FDA is pleased by House and
Senate passage of both of these important measures."

Full text:
http://www.swnebr.net/newspaper/cgi-bin/articles/articlearchiver.pl?156146

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