Wedgewood Pharmacy continues to compound 17P following FDA rejection of new drug application by KV Pharmaceutical Co.

(Swedesboro NJ, February 4, 2009) Wedgewood Pharmacy will continue to compound 17-AlphaHydroxyprogesterone Caproate (17P) following the Federal Drug Administration’s (FDA) January 26 rejection of KV Pharmaceutical Co.’s application to seek New Drug Approval for the substance.

The drug, a form of the hormone progesterone, is prescribed by physicians for patients who are at risk of delivering prematurely. Each year, there are nearly 500,000 premature births in the U.S.  Wedgewood Pharmacy has compounded 17P since 2003, when researches reported in the New England Journal of Medicine that 17P may decrease the incidence of pre-term birth among women considered at high risk for spontaneous delivery.  

According to the New York Times, in a study of women who received weekly injections of 17P the rate of premature births was lowered by more than one-third.  Researchers considered the treatment so effective that the study was stopped early because it would have been unethical to continue to administer a placebo to some of the high-risk women in the study group.

About Wedgewood Pharmacy

A compounding pharmacy creates customized preparations for individual patients in response to a licensed practitioner’s prescription.  Wedgewood Pharmacy is one of the largest compounding pharmacies in the United States, providing more than 25,000 prescribers with compounded preparations.  It is located in Swedesboro NJ and licensed throughout the United States.
Wedgewood Pharmacy maintains strict quality controls. Pharmacists prepare prescriptions in a 40,000 square-foot state-licensed facility that houses four independently certified Class 1000 clean rooms, Class 100 laminar airflow hoods and laboratory suites with HEPA filtrataion. Wedgewood Pharmacy was one of the first pharmacies committed to the stringent requirements of Chapters <795> and <797> of the United States Pharmacopeia.

Background: About Compounding Pharmacy

Because every patient is different and has different needs, customized, compounded preparations are a vital part of quality medical care.
The basis of the profession of pharmacy has always been the "triad," the patient-physician-pharmacist relationship.  Compounding is extremely important to the healthcare community, which often requires flavors, dosages and potency levels that commercially available medications cannot provide.
Through this relationship, patient needs are determined by a doctor, who chooses a treatment regimen that may include a compounded preparation. Physicians often prescribe compounded preparations for reasons that include (but are not limited to) the following situations:
When needed medications are discontinued by or generally unavailable from pharmaceutical companies, often because the medications are no longer profitable to manufacturer
When the patient is allergic to certain preservatives, dyes or binders in available off-the shelf medications
When treatment requires tailored dosage strengths for patients with unique needs (for example, an infant)
When a pharmacist can combine several medications the patient is taking to increase compliance
When the patient cannot ingest the medication in its commercially available form and a pharmacist can prepare the medication in cream, liquid or other form that the patient can easily take
When medications require flavor additives to make them more palatable for some patients, most often children

    For additional information, visit the International Academy of Compounding Pharmacists’ Web site at IACPRx.org and CompoundingFacts.org.