Business Insider

Slayback Pharma announces FDA approval of Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 mL in a multi-dose vial, the first generic equivalent of Makena® Injection ...

PRINCETON, N.J., Jan. 2, 2019 /PRNewswire/ -- Slayback Pharma LLC announced today that the U.S. Food and Drug Administration ("FDA") granted approval of its abbreviated new drug application ("ANDA") ...
Nasdaq

AMAG Pharmaceuticals Announces Topline Results From the PROLONG Trial Evaluating Makena® (hydroxyprogesterone caproate injection)

WALTHAM, Mass., March 08, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today topline results from PROLONG (Progestin's Role in Optimizing Neonatal Gestation), a ...
Nasdaq

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)

WALTHAM, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is ...
Monthly Prescribing Reference

FDA Proposes Makena Be Withdrawn From the Market

Makena received accelerated approval in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Food and Drug ...
Monthly Prescribing Reference

FDA Panel Recommends Makena Be Withdrawn From the Market

Credit: FDA. The product was granted approval through the accelerated approval pathway in 2011. Following a 3 day meeting, the Food and Drug Administration’s (FDA) Obstetrics, Reproductive, and ...
FiercePharma

FDA experts vote to pull AMAG's premature-birth med Makena from the market

Already under pressure from its shareholders, AMAG faced a big decision from an FDA advisory committee on the future of its troubled premature-birth med Makena. Now, with the committee voting against ...
NPR

Controversy Kicks Up Over A Drug Meant To Prevent Premature Birth

An independent panel of advisers to the Food and Drug Administration recommended last week that a medication to prevent preterm birth be taken off the market because, the advisers decided, the ...
FiercePharma

Covis granted FDA hearing in latest twist over controversial premature-birth med Makena

Nearly two years after an FDA advisory panel determined Covis Pharma’s controversial premature-birth med Makena should be taken off the market after failing a key post-approval study, the agency is ...
CNN

FDA panel recommends withdrawing approval of Makena drug, used to prevent preterm births

The 9-7 vote, which took place at a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on Tuesday, came in response to evidence suggesting that the drug was not effective. The ...
NBC News

FDA panel recommends revoking the approval of controversial drug for preterm births

An advisory panel to the Food and Drug Administration voted Wednesday to take a drug intended to prevent premature births off the market, saying that it remains doubtful that the drug works. The ...
Wall Street Journal

FDA Forces the Only Drug for Preterm Births to Leave Market

The only drug on the market to help prevent preterm births must stop being sold immediately, a move that comes after scientists at the Food and Drug Administration earlier determined it was ...