• Regulatory NewsRegulatory News

    FDA seeks withdrawal of Makena, generics from market

    The US Food and Drug Administration (FDA) on Monday proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a postmarket study failed to confirm clinical benefit.   The request comes nearly a year after FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee recommended that the agency withdraw its approval for the drug and more than nine years after it received accelera...
  • Regulatory NewsRegulatory News

    Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

    Earlier this week, an FDA advisory committee recommended that the agency withdraw Amag Pharmaceutical’s preterm birth drug Makena, a treatment that brought in more than $1 billion in sales before failing a confirmatory trial. The agency is now faced with the task of whether to take the committee’s vote and pull Makena from the market or allow it to remain until another confirmatory trial can be completed. Keeping Makena on the market would also present a rare situation,...
  • Warning Letter Resurrects Issue of Makena and FDA's Use of Enforcement Discretion

    A Warning Letter sent by the US Food and Drug Administration (FDA) this week offers yet another addition in the long and interesting chapter of KV Pharmaceuticals' Makena (17-hydroxyprogesterone  caproate). Background In 2011, FDA approved Makena under an orphan drug designation. While the drug had been used by doctors for years to prevent premature births, KV was the first company to bring Makena through clinical testing. Under the terms of FDA's approval, all...
  • In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld

    A lawsuit filed by KV Pharmaceuticals against the US Food and Drug Administration (FDA) was thrown out of court on 6 September 2012 after a judge ruled the company could not challenge activities falling under FDA's enforcement discretion. KV filed its suit against FDA in July 2012 over FDA's allowance of compounded versions of its anti-premature pregnancy drug Makena (17P / hydroxyprogesterone caproate injection) to remain on the market. A Long-Running Saga The long...
  • Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy

    Missouri-based KV Pharmaceutical , the manufacturer of pre-term birth prevention compound Makena (hydroprogesterone caproate injection), has filed for bankruptcy in federal court citing the US Food and Drug Administration's (FDA) "lack of enforcement" of the company's marketing exclusivity rights, reports Bloomberg . The filing could mark a final chapter in a long-running and often controversial saga between KV and FDA. The entire matter stems FDA's 2011 approva...
  • FDA: Challenge to Enforcement Discretion Without Standing, Merit

    Are the US Food and Drug Administration's (FDA) discretionary enforcement actions beyond industry reproach? In a recent court filing, lawyers for the US regulators argue they are, especially as discretionary actions-and statements of intended actions-relate to a specific court case filed by Minneapolis-based KV Pharmaceutical. In a July filing before the US District Court in DC , KV argued FDA had used enforcement discretion to "unlawfully" promote competition to its dr...
  • Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion

    Minneapolis-based K-V Pharmaceutical has a problem: its flagship product, Makena, isn't maturing into the cash-generating product the company hoped it would become, leaving the company to face likely financial ruin if its cash-flow situation doesn't improve dramatically within the next few months. The company's hopes for dramatic change may rest squarely on the success of a lawsuit it filed on 5 June. Reuters reports the company has filed suit against the US Food and...
  • FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena

    The US Food and Drug Administration (FDA) has announced the results of an investigation into compounded versions of KV Pharmaceutical's Makena (hydroxyprogesterone caproate), used to prevent pre-term births, which the company alleged were compounded to a lesser standard than allowed under the company's approved New Drug Application (NDA). The agency said in a statement it would continue to allow compounding of the drug after its investigation yielded no significant concer...