Headquartered in St. Louis, Missouri, KV Pharmaceutical is a specialty pharmaceutical company with a focus on women’s healthcare. Through our operations subsidiary, Ther-Rx Corporation, we develop, distribute, and support a portfolio of pharmaceutical products that healthcare providers can prescribe with confidence, and pharmacists can dispense with trust. Ther-Rx’s employees are passionately committed to advancing the health of women across all the stages of her life. Click here to learn more about us.
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K-V Pharmaceutical Company Files Voluntary Petitions for Reorganization to Restructure Financial Obligations
Company continues to operate its businesses and serve the needs of healthcare providers and patients
St. Louis, MO, August 4, 2012 – K-V Pharmaceutical Company (NYSE: KVa/ KVb) (“K-V” or “the Company”) and certain of its domestic subsidiaries today filed voluntary Chapter 11 petitions under the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York, seeking the protection of Chapter 11 while it seeks to restructure its financial obligations.
The Company intends to continue to operate during the reorganization, subject to the supervision and orders of the Bankruptcy Court and in accordance with applicable provisions of the Bankruptcy Code, paying employees and vendors in the normal course of business for goods and services provided postfiling, and providing its women’s health care products without interruption to meet the needs of the healthcare providers and patients it serves.
Click here to view the full Company Statement.
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FDA Issues Further Guidance About Makena®
FDA recommends healthcare providers prescribe FDA-approved Makena first-line for clinically-indicated patients
St. Louis, MO – July 2, 2012 – K-V Pharmaceutical Company (the “Company”) (NYSE: KV.A/KV.B) today addressed the additional guidance provided by the U.S. Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena®). FDA provides further guidance to healthcare providers and pregnant women at high risk for recurrent preterm birth, recommending the use of FDA-approved Makena® rather than compounded drug formulations of hydroxyprogesterone caproate. The agency also describes its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. Makena® is the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Click here to view the full Company Statement.
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FDA and CMS Issue Important Updates on Makena®
FDA Emphasizes That it is Applying its Normal Enforcement Policies for Compounded Drugs to Compounded Hydroxyprogesterone Caproate
CMS Reminds States of their “…responsibility to cover FDA-approved products"
St. Louis, MO—June 18, 2012— K-V Pharmaceutical Company (“the Company”) (NYSE: KV.A/KV.B) announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth. Prior statements by both agencies had been cited by some payers as the basis for denying patients’ access to FDA-approved Makena in favor of unapproved compounded hydroxyprogesterone caproate (17P) formulations.
Click here to view the full Company Statement.
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