approvable

The number of so-called approvable letters, which typically postpone FDA decisions pending more data, increased by 40% last year, according to a unit of Sagient Research Systems Inc., which tracks the regulatory paths of drugs.

Drug Makers Say FDA Safety Focus 2008

In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin.

FDA Says it Has 'Outstanding Issues' 2008

The Palo Alto, Calif., specialty-pharmaceutical company received a so-called approvable letter -- which typically indicates the agency needs more information before it will approve a drug -- from the Food and Drug Administration for the Luvox CR extended-release capsule to treat two anxiety disorders.

Lindsay, Mobile Mini Post Gains 2007

The second medicine, an antibiotic that would also be aimed mostly at hospital infections, received a so-called approvable letter last year, meaning that the FDA wants to see more data.

Pfizer's Anti-Fungal Treatment Approved 2006

These Byzantine "approvable" letters that mandate trial after trial for indications that companies haven't even asked for in their filings cause financial pain, loss of key employees, and, worst of all, loss of investor confidence, thus raising the cost of drug development far beyond what should be reasonably expected.

No Moving the Goalpoasts, Once Trials Start 2008

A New FDA Snag Wyeth was dealt an additional setback with bazedoxifene, a proposed treatment for postmenopausal osteoporosis, as it received another "approvable" letter from the Food and Drug Administration.

Wyeth Drug Hits 2008

Antidepressant duloxetine considered 'approvable' by FDA.

The FDA Guerillas of Wonky DrugWonks - Part I 2008

But the agency has given Boston Scientific an "approvable" letter that indicates it will OK the stent when it lifts a new-product moratorium it imposed on the company two years ago for reasons unrelated to the Liberte application.

Boston Scientific Stent Study Flawed 2008

Antidepressant duloxetine considered 'approvable' by FDA.

Glaxo Fights Against Public Paxil Trials 2008

The Warrington, Pa., biotechnology company said it received another "approvable" letter from the Food and Drug Administration for its product to treat a breathing problem in premature babies.

Natco, PetroQuest Rise; Standard Pacific Falls 2008