Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI), Friday said their progesterone vaginal gel was not recommended for approval by an advisory panel of the Food and Drug Administration.
According to the panel, data provided by the company was insufficient to prove the product to be efficient in reducing the risk of preterm birth in women with short cervical length. Following the news, shares of Columbia tumbled down over 62 percent in extended hours trading.
The members of Advisory Committee for Reproductive Health Drugs generally agreed that progesterone vaginal gel is safe, however the panel voted 13-4 stating they needed more information to support approval.
The FDA is expected to take a final decision on the gel by February 26, 2012. Although the regulatory agency considers the recommendations of its advisory panels, such recommendations are not binding.
Frank Condella, CEO of Columbia Laboratories, said, "We will work with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our NDA. We remain confident in the Pregnant study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy."
CBRX closed Friday's regular trading session at $1.58 on the Nasdaq. However, the stock lost $0.98 or 62.28% in after-hours trade.
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