This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

K-V Pharmaceutical Comments On ACOG And SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ And Compounded 17P

In the news release, K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P, issued Oct. 13, 2011 by K-V Pharmaceutical Company over PR Newswire, we are advised by a representative of the company that there have been updates to the release. Please disregard the original transmission. The complete, updated release follows:

K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding 17-Alpha Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P

ST. LOUIS, Oct. 13, 2011 /PRNewswire/ -- K-V Pharmaceutical Company (the "Company") (NYSE: KV.A/KV.B) appreciates that the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) have issued an information update that ensures healthcare providers, patients, and the payer community have the facts regarding FDA-approved Makena™.  The information update emphasizes that previous ACOG and SMFM statements regarding Makena were not intended to be used by private or public payers as a basis for interfering with the medical judgment of healthcare providers or denying patient access to Makena.  It also states that physicians should understand the inherent differences between an FDA-approved manufactured product and a compounded preparation, and that ACOG and SMFM's previous statements were not meant to suggest that Makena and compounded 17P are identical products.  

Healthcare providers understand that evidence-based medicine is the foundation of clinical practice.  Evidence from the NICHD MFMU Network study (Meis, et al.) supporting the use of hydroxyprogesterone caproate (17P) was based on drug manufactured under FDA's Good Manufacturing Practices (GMP) conditions, and not on drug made using compounding processes or obtained from compounding pharmacies.  The drug used in the NICHD study is available today as FDA-approved Makena.  

Access to FDA-approved Makena for clinically-indicated patients is an important public health priority.  Certain payer coverage policies have been influenced by a belief that unapproved compounded 17P formulations are the same as Makena.  These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare provider's medical judgment.  

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.02 -2.67%
FB $104.07 -5.81%
GOOG $683.57 -3.45%
TSLA $162.60 -7.26%
YHOO $27.97 -4.05%


Chart of I:DJI
DOW 16,204.97 -211.61 -1.29%
S&P 500 1,880.05 -35.40 -1.85%
NASDAQ 4,363.1440 -146.4150 -3.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs