kv pharma

FDA Says No Action to KV Pharma on Pre-Term Birth Drug

Published on Wed, 03/30/2011 - 15:02
By FNNO Staff in General Interest, KV.A, drug, fda, health, kv pharma, medical, pharmaceutical, pharmacy, preterm birth, regulation, News Update

However, the FDA did say it may at any time revisit a decision to exercise enforcement discretion, leaving some room open for future regulatory enforcement regarding compounding the drug, Reuters reported.

drug, fda, health, kv pharma, medical, pharmaceutical, pharmacy, preterm birth, regulation

K-V Pharmaceuticals (KV.A) slides after the FDA says it does not plan to take enforcement action against pharmacies that compound KV.A's pre-term birth drug based on a valid prescription.

By FNNO Staff
fnnonline@gmail.com

Hologics Preterm Birth Drug Makena Receives FDA Approval

Makena, previously called Gestiva, has faced years of delays at the FDA, which issued an "approvable" letter for the drug in October 2006, but delayed further action in January 2009. The agency requested more information on the dr

hologic, holx, drug, makena, premature birth, fda, gestiva, approval, medicine, health care, trial, clinical benefit, babies, infants, kv pharma, deal, cash, payment, financial, assets

Hologic (HOLX) is down fractionally in choppy trade around the even mark, after announcing today that its drug, Makena, designed to prevent premature birth, was approved by the U.S. Food and Drug Administration, but it added that

By Stephanie Shyu
sshyu@fnno.com

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