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Home » Keywords » FDAnews Drug Daily Bulletin

Items Tagged with 'FDAnews Drug Daily Bulletin'

ARTICLES

Wyeth to Answer FDA Reinspection Findings in Guayama Facility

April 13, 2007

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.

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Grassley Requests Zyprexa Marketing Documents

April 13, 2007

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.

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Kennedy Introduces PDUFA Reauthorization; Bill Alters Pediatric Exclusivity

April 13, 2007

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.

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Supreme Court Rejects Generic Lipitor Case

April 12, 2007

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.

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Analysis Finds Lower Heart Risk With Hormone Therapy for Women in Their 50s

April 12, 2007

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).

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GSK Warns of Label Tampering on HIV Medications

April 12, 2007

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.

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Updated FDA Manual Instructs Inspectors to Cite Firms for Not Submitting AERS Reports

April 11, 2007

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).

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Purdue Pharma Settles Generic OxyContin Suit Against Impax

April 11, 2007

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.

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FDA Advisory Committee to Review Merck's Arcoxia

April 11, 2007

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.

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Roche Adds Antibody Discovery Platform With THP Acquisition

April 10, 2007

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

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