Navigation Links
FDA Statement on Makena
Date:11/8/2011

SILVER SPRING, Md., Nov. 8, 2011 /PRNewswire-USNewswire/ -- FDA approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth.  For many years before Makena was approved, a version of the active ingredient of Makena has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug.  In March 2011, after learning that the owner of Makena, K-V Pharmaceuticals, had sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena, FDA issued a statement about compounded hydroxyprogesterone caproate to clarify the agency's enforcement priorities.  In the March 2011 statement, FDA explained that the agency prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.  The agency also stated:

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

In October 2011, FDA received information from K-V Pharmaceuticals regarding the potency and purity of samples of bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products.  According to the analysis of this information provided by K-V, there is variability in the purity and potency of both the bulk APIs and compounded hydroxyprogesterone caproate products that were tested.  Although FDA has not validated or otherwise confirmed the analyses provided by K-V, FDA has carefully reviewed the data and will conduct an on-site review of the laboratory analyses.

FDA has begun its own sampling and analysis of compounded hydroxyprogesterone caproate products and the bulk APIs used to make them.  That process is ongoing.  In the meantime, we remind physicians and patients that before approving the Makena new drug application, FDA reviewed manufacturing information, such as the source of the API used by its manufacturer, proposed manufacturing processes, and the firm's adherence to current good manufacturing practice.   Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cempra Holdings, LLC Files Registration Statement for Proposed Initial Public Offering
2. Alere Inc. Statement Regarding Recommended Increased Cash Offer to Acquire Axis-Shield
3. Alere Inc. Statement Regarding Axis-Shield Offer
4. Alere Inc. Statement Amending Acceptance Condition to Axis-Shield Offer
5. Visual Healthcare Corp. Files Year-End Disclosure Statement
6. Statement from the Michigan Society of Anesthesiologists in Response to Governor Snyders Health & Wellness Announcement
7. Vycor Medical, Inc. Files Restated Financial Statements
8. Vycor Medical, Inc. Restatement of Financial Statements
9. Argos Therapeutics Files Registration Statement for Proposed Initial Public Offering
10. Statement on Availability of Primatene® Mist CFC
11. Jonah and Dina Shacknai Issue Statement Regarding the Release of Paradise Valley Police Reports
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- One of Australia,s successful biotechnology scientists, ... new biotechnology company, Noxopharm Limited [ABN 50 608 966 123] ("Noxopharm"). ... list on the ASX. Noxopharm is a clinic-ready company ... Phase 1 clinical study later this year. ... biggest problems facing cancer patients - the ability of cancers to ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... Maryland (PRWEB) , ... June 24, 2016 , ... ... Angels is actively feeding the Frederick area economy by obtaining investment capital for ... over the past 2½ years that have already resulted in more than a ...
Breaking Medicine News(10 mins):