KV-Pharma (KV-A) Rips 50%+ as FDA Will Further Test Makena Compounds, Places No Restrictions at This Time
KV-Pharmaceutical (NYSE: KV-A)(NYSE: KV-B)(NYSE: KV.A)(NYSE: KV.B) shares are ripping higher today, following a Food and Drug Administration (FDA) statement on Makena.
Last March, the FDA said it wouldn't "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."
KV-Pharma shares are reacting today on the FDA's state ment that "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.
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."
KV-Pharma shares are now up 56 percent Tuesday following trading pauses for volatility.
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Last March, the FDA said it wouldn't "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."
KV-Pharma shares are reacting today on the FDA's state ment that "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.
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."
KV-Pharma shares are now up 56 percent Tuesday following trading pauses for volatility.
Get immediate access to market moving news and alerts with StreetInsider.com Premium - FREE TRIAL!
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