Por: RTTNews Health April 10, 2023
The FDA has announced Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. The drug that had been approved under the accelerated approval pathway was used to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. In 2011, the FDA approved Makena under the accelerated approval pathway based on a determination that the sponsor had showed... + full article
ABC News USA Health March 08, 2023
WASHINGTON -- The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to force it from the market.The drug, Makena, is a synthetic... + más
FDA holds hearing to remove pregnancy drug from market, company pushes back | WGN-TV
Maker of unproven birth drug Makena to pull from US market | Associated Press
Associated Press USA Politics March 08, 2023
WASHINGTON (AP) — The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to .The drug, Makena, is a synthetic version of the... + más
Maker of unproven birth drug Makena to pull from US market | ABC News
Portland Press Herald USA Health October 19, 2022
WASHINGTON — Federal health advisers have concluded that a drug intended to prevent premature births hasn’t been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. A panel of federal advisers says Makena,... + más
FDA panel backs removal of unproven pregnancy drug | WPLG Local 10
FDA panel backs removal of unproven pregnancy drug | 10 WBNS
NBC 6 South Florida USA World October 19, 2022
Makena Federal health advisers have concluded that a drug intended to prevent premature births hasn't been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. The ’s advisory panel voted 14-1 Wednesday... + más
FDA panel recommends revoking the approval of controversial drug intended to prevent premature birth | CNBC
FDA panel backs removal of unproven pregnancy drug | Portland Press Herald
WGN-TV USA Nation October 17, 2022
WASHINGTON (AP) — The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work. A Food and Drug Administration meeting that opened... + más
ALS drug wins FDA approval despite questionable data | ABC News
FDA pushes to remove pregnancy drug, company pushes back | WPLG Local 10
WPLG Local 10 USA Politics October 17, 2022
WASHINGTON – The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn't work.A Food and Drug Administration meeting that opened Monday... + más
FDA pushes to remove pregnancy drug, company pushes back | ABC News
Politico USA Health October 16, 2022
The FDA will make its case this week to do something it hasn’t in over a decade — order a drug it expedited to the market to be pulled. A panel of independent expert advisers on obstetric and reproductive drugs will meet starting Monday to decide whether to recommend that... + más
ALS drug wins FDA approval despite questionable data | PennLive
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