Subject: | |
From: | |
Reply To: | |
Date: | Tue, 4 Oct 2011 10:30:33 -0400 |
Content-Type: | text/plain |
Parts/Attachments: |
|
|
I noticed a post regarding Domperidone in the United States and thought I would copy the article below from the US Lactation Consultant Association September eNews regarding Domperidone.
Marsha Walker, RN, IBCLC
Weston, MA
Over the last few months, USLCA has been working in conjunction with Dr. Thomas Hale from
the Infant Risk Center at Texas Tech University towards obtaining approval from the Food and
Drug Administration (FDA) for the use of Domperidone for breastfeeding mothers experiencing
insufficient breastmilk. U.S. Clinicians have long been unable to (or only with difficulty) offer
this option to selected mothers experiencing insufficient milk production. The first step in this
process was to obtain orphan drug status for Domperidone. The Orphan Drug Designation
program provides orphan status to drugs and biologics, defined as those intended for the safe
and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer
than 200,000 people in the U.S. The approval of an orphan designation does not alter the
standard regulatory requirements and process for obtaining marketing approval. Safety and
efficacy must still be established through adequate and well controlled studies, but the orphan
status qualifies for grants to conduct such studies. The FDA granted orphan drug status to
domperidone for "treatment of hypoprolactinemia in breastfeeding mothers, and in some
hypoprolactinemic conditions following the use of cabergoline or bromocriptine in mothers who
wish to return to breastfeeding." Once the required studies are conducted, they are submitted to the FDA for final marketing approval. USLCA and Dr. Hale are working on the next stage
of this process which is to apply for grants to conduct the FDA required clinical trials with the
hope of eventually obtaining marketing approval for Domperidone. Dr. Hale has been instrumental in collecting the required information and filing the application for orphan drug status.
His intense work and command of the subject were invaluable in making it this far. While the
process for FDA approval of the use of Domperidone is a lengthy one, we are well on our way
to hopefully being able to provide this option for the mothers who may need it so desperately.
***********************************************
Archives: http://community.lsoft.com/archives/LACTNET.html
To reach list owners: [log in to unmask]
Mail all list management commands to: [log in to unmask]
COMMANDS:
1. To temporarily stop your subscription write in the body of an email: set lactnet nomail
2. To start it again: set lactnet mail
3. To unsubscribe: unsubscribe lactnet
4. To get a comprehensive list of rules and directions: get lactnet welcome
|
|
|