FDA/CDC
FDA/CDC
FDA approves first generics of pregabalin
The first generic approvals of the drug were granted to nine companies.
FDA/CDC
Cannabis: Doctors tell FDA to get out of the weeds
Unregulated use of cannabidiol was the chief concern of many physicians.
FDA/CDC
FDA expands use of Vraylar to treatment of bipolar-associated depressive episodes
Approval of the expanded label was based on results of three trials.
News from the FDA/CDC
CDC warns against misuse of opioid-prescribing guideline
Officials at the Centers for Disease Control and Prevention are advising against misapplication of the agency’s guideline on opioid prescribing....
FDA/CDC
Alvogen issues recall for mislabeled fentanyl patches
The recall was issued because a small number of cartons labeled as containing 12 mcg/h patches contained 50 mcg/h patches.
FDA/CDC
FDA approves generic naloxone spray for opioid overdose treatment
The agency said the naloxone nasal spray does not need assembly and can be used by anyone, regardless of medical training.
FDA/CDC
FDA modifies safety label for Addyi
The boxed warning no longer suggests total abstinence from alcohol.
FDA/CDC
FDA to expand opioid labeling with instructions on proper tapering
The label changes are intended to be used when both the clinician and patient have agreed to reduce the opioid dosage.
Feature
FDA chief calls for stricter scrutiny of electronic health records
The government spent more than $36 billion over 10 years to switch to digital records. In that time, thousands of reports of deaths, injuries, and...
FDA/CDC
FDA approves brexanolone for postpartum depression
Brexanolone, which will be marketed under the brand name Zulresso, is the first pharmacotherapy approved for treating postpartum depression.
Latest News
FDA approves intranasal esketamine for refractory major depressive disorder
Under the FDA-required REMS, prescribers must complete specific training; the drug must be adminstered in office to allow for patient monitoring...