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:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center for ... Table in Battle Creek, MI, where the rehabilitation facility is located. This annual celebration ... world’s leading providers of cereal and other breakfast foods. Its residents often refer to ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and ... their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took ... the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive ...
(Date:6/24/2016)... ... 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. ... the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has ... , Sickle Cell Disease (SCD) is a disorder of the red blood cells, which ...
Breaking Medicine News(10 mins):