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A new epidemiologic study of GlaxoSmithKline’s (GSK) top-selling antidepressant Paxil suggests the drug may be associated with an increased risk of birth defects compared to other antidepressants, GSK states in a recently issued “Dear Healthcare Professional” letter.
Savient Pharmaceuticals has filed its second citizen petition with the FDA in two years to block generic versions of its anti-weight-loss drug Oxandrin.
In an apparent move to bolster its heart-failure treatment Natrecor, Johnson & Johnson’s (J&J) Scios unit has launched a comprehensive physician education program for the embattled drug, which clinical research has linked to an increased risk of kidney malfunctions.
The pharmaceutical industry wants to shorten the time it takes a drugmaker to revise a product label with the FDA — a proposal that comes as lawmakers are pushing legislation that would give the FDA authority to mandate labeling changes.
The plan by the FDA to post emerging drug-safety information on a proposed Drug Watch website raises serious public policy and legal concerns, and may be inconsistent with federal law, according to PhRMA.
The FDA’s plan to publicize emerging drug-safety information through its proposed Drug Watch website raises serious public policy and legal concerns, and may be inconsistent with federal law, PhRMA argues in recent comments submitted to the agency.
PhRMA wants to shorten the time it takes a pharmaceutical firm to revise a drug label with the FDA — a proposal that comes as lawmakers are pushing legislation that would give the FDA authority to mandate labeling changes.
The FDA has approved a new black-box warning for Pfizer’s arthritis pain drug Celebrex that highlights the increased risk of cardiovascular (CV) events associated with the product.
The FDA would be open to reforms granting it the power to require changes to drug labeling, but the agency’s existing authority is currently sufficient to meet its responsibilities to protect public health, FDA Commissioner Lester Crawford told House lawmakers July 26.
The FDA has updated the labeling for three prominent erectile dysfunction drugs to indicate the products might be linked to a small number of postmarketing reports of sudden vision loss.