- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- Diplomat becomes distributor of recently approved cancer drug
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- Senate passes Drug Quality and Security Act
- FDA advisory panel to consider OTC status of NSAIDs
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”