FDA Approvals - Relief -- and some bitter pills (The Star-Ledger) WASHINGTON --
Relief -- and some bitter pills (The Star-Ledger)
WASHINGTON -- The House and Senate have given final approval to far-reaching legislation broadening the Food and Drug Administration's prescription drug safety powers, providing greater disclosure of drug risks and promising the pharmaceutical industry timely reviews and approvals of new medicines.
Cadila gets US FDA approval for hydroxychloroquine sulfate tabs (PharmaBiz)
Cadila Healthcare Ltd has received an approval from the US FDA for hydroxychloroquine sulfate tablets in the strength of 200 mg. The drug falls in the DMARD (Disease Modifying Anti-Rheumatic Drug) segment and is used in the management of rheumatoid arthritis.
FDA Accepts sNDA for Expanded Use of Angiomax(R) (bivalirudin) (Business Wire via Yahoo! Finance)
PARSIPPANY, N.J.----The Medicines Company said today that the U.S. Food and Drug Administration has accepted the Company's supplemental new drug application for a modified dosing regimen of Angiomax for the treatment of acute coronary syndromes , specifically in patients with unstable angina or non-segment elevation myocardial infarction .