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") ...
Business Insider

AMAG Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for Makena® (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector

WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug ...
CNN

ANI Pharmaceuticals Announces Launch of Hydroxyprogesterone Caproate Injection USP, 250mg/mL

BAUDETTE, Minn., June 28, 2016 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the commercial launch of Hydroxyprogesterone Caproate Injection ("HPC") USP 250mg/mL in ...
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 ...
JD Supra

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

Makena’s new drug application (“NDA”) was approved in 2011 under FDA’s accelerated approval process, which allows FDA to approve drugs for serious conditions that fulfill an unmet clinical need before ...
Healio

Covis Pharma to voluntarily withdraw preterm birth prevention drug from market

Please provide your email address to receive an email when new articles are posted on . Covis Pharma will voluntarily withdraw its preterm birth prevention drug Makena from the market. An FDA advisory ...
Healio

ACOG session offers updates, recommendations for drugs to prevent recurrent preterm birth

Please provide your email address to receive an email when new articles are posted on . Hydroxyprogesterone caproate is not recommended to prevent recurrent preterm birth. Vaginal progesterone may be ...
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FDA Proposes Makena Be Withdrawn From the Market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 ...
Medscape

FDA Proposes Withdrawing Makena's Approval

Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research (CDER) ...
BioWorld

In the clinic

Amag Pharmaceuticals Inc., of Waltham, reported results from its pharmacokinetic study designed to demonstrate comparable bioavailability of the subcutaneous auto-injector product and the current ...
BioWorld

Items Tagged with 'hydroxyprogesterone'

Nine years after Amag Pharmaceuticals Inc.’s Makena (hydroxyprogesterone caproate injection) received accelerated approval to reduce the risk of preterm birth in certain at-risk pregnancies, the FDA ...