Development in the syllabus of Pharmaceutical Marketing & Management that is studied in the Bachelor of Pharmacy course of Bangladeshi Universities.        LOSECTIL stands beside acid survivors        Vitamin D Levels Linked to Parkinson's Symptoms        Keeping the newborn warm at home at winter        Itís time to prevent cervical cancer        Huge Rise in CT, MRI, Ultrasound Scan Use: Study        Exercise May Delay Early Aging of People With Diabetes        Alzheimer's Drug Shows Some Promise in Trials        Obesity, Depression Blamed for Daytime Sleepiness Epidemic        Fruits, Veggies May Help Smokers Quit     

Member Sign In
Forgot Your
Username & Password?


Not a Member?
Please Sign Up Here


 
 
Sr. Executive / Executive, Production; THE IBN SINA PHARMACEUTICAL IND LTD

 
Approval of Makena Injection (hydroxyprogesterone caproate) by FDA
Brand Name: Makena Injection
Generic Name: hydroxyprogesterone caproate
Company Name: Hologic, Inc.
Date of Approval: February 3, 2011
Treatmant for: Premature Labor
The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

The FDA approved Makena under the agency's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit.

Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit. An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena. Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.

"Preterm birth is a significant public health issue in the United States," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "This is the first drug approved by the FDA that is indicated to specifically reduce this risk."

A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women 16 to 43 years of age who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to 5 years reached similar developmental targets, regardless of the mother's treatment. The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018. That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Makena is manufactured by Baxter Pharmaceutical Solutions LLC, based in Bloomington, Ind.
Note: To know more please go to the following sources.
Update: 2011-02-04
Source: Drugs.com & FDA
 
Other FDA Approval
Approval of Adcetris (brentuximab vedotin) by FDA
Approval of Benlysta Injection (belimumab) by FDA
Approval of laViv (azficel-T) by FDA
Approval of Ferriprox (deferiprone) by FDA
Approval of Horizant (gabapentin enacarbil) by FDA
Approval of Juvisync Tablets (simvastatin and sitagliptin) by FDA
Approval of Gadavist Injection (gadobutrol) by FDA
Approval of Lazanda Nasal Spray (fentanyl) by FDA
See all the FDA Approval