Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
A boxed warning for testosterone on major adverse cardiovascular events is out and a new blood pressure warning is in, the ...
The agency is advising people to avoid misusing or inhaling the products that are marketed as whipped cream chargers but have ...
The FDA has recommended several labeling changes to all approved testosterone replacement therapy products based on the ...
“Abrupt” reductions in antidepressant treatment “ranging from 20 percent to 50 percent” Increases in psychotropic drug ...
WASHINGTON (AP) — U.S. health officials are tracking a rise in injuries tied to the misuse of nitrous oxide, or laughing gas, ...
Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
The FDA has announced new labeling changes for all testosterone products following a review of clinical trial data, including a TRAVERSE study and postmarket ambulatory blood pressure studies.
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