The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has announced significant developments following the 8th Working Group on Trade meeting between India and Taiwan. The discussions centered on enhancing cooperation in the pharmaceutical sector, with a particular focus on the supply of 72 active pharmaceutical ingredients (APIs) from India to Taiwan.
April 6 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday withdrew its approval for Covis Pharma's preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.
The maker of a controversial drug for preterm birth has decided to withdraw the hormonal treatment, bringing to an close a lengthy battle with the Food and Drug Administration over its continued use.
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 giving the company a chance to plead its case.
The US Food and Drug Administration is standing by its October 2020 recommendation that Makena (intramuscular17-hydroxyprogesterone caproate, or 17-OHPC) be withdrawn from the market, notwithstanding a new meta-analysis of the efficacy of progestogens for prevention of preterm birth.
WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.
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.
Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and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) at the US Food and Drug Administration (FDA).
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.
Luxembourg-based Covis Group is set to acquire Massachusetts-based AMAG Pharmaceuticals in a new deal worth approximately $647 million on an enterprise basis, including debt, it has emerged.