Items Tagged with 'FDAnews Drug Daily Bulletin'

Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company's Guayama, Puerto Rico, manufacturing facility, the firm announced.

As part of a Senate Finance Committee investigation, Sen. Chuck Grassley (R-Iowa) is requesting information from Eli Lilly regarding the marketing of its antipsychotic drug Zyprexa.

Sen. Edward Kennedy (D-Mass.) introduced the Prescription Drug User Fee Act (PDUFA) reauthorization last week, proposing a new structure that would increase the agency's user fees by more than $100 million.

The U.S. Supreme Court will not make a determination on Ranbaxy's challenge of the validity and enforceability of Pfizer's main Lipitor patent, the courtsaid last week.

A new analysis of previously conducted studies showed no increase in coronary heart disease for women in their 50s who take hormone therapies close the start of menopause, according to an article in The Journal of the American Medical Association (JAMA).

A third party tampered with the labels on two GlaxoSmithKline (GSK) HIV infection medications, placing incorrect and counterfeit labels on the products, the company and the FDA announced.

The FDA added noncompliance with regulations covering submissions of postmarketing adverse event drug reports to the list of reportable Form 483 observations that should be cited during FDA inspections, according to the 2007 Investigations Operations Manual (IOM).

Impax Laboratories has acknowledged the validity and enforceability of a key patent held by Purdue covering its pain treatment OxyContin, according to a settlement agreement reached by both companies.

An increased risk of side effects from Merck's potential Vioxx successor Arcoxia indicates the drug should not be approved unless it fills an unmet need, an FDA employee told an advisory committee.

Roche expanded its preclinical drug-discovery platforms with a $56.5 million acquisition of Therapeutic Human Polyclonals (THP), the firm said.