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. ❋ Unknown (2008)
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. ❋ Unknown (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. ❋ Unknown (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. ❋ Unknown (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. ❋ Unknown (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. ❋ Unknown (2008)
Antidepressant duloxetine considered 'approvable' by FDA. ❋ Unknown (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. ❋ Unknown (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. ❋ Unknown (2008)
In a separate setback, Wyeth, of Madison, N.J., also announced that the Food and Drug Administration issued a second "approvable" letter for its osteoporosis drug bazedoxifene, meaning further delay before the medicine reaches the market. ❋ Unknown (2007)
In addition, a number of medicines previously granted marketing approval in Europe have received "approvable," instead of approval, letters from the FDA, meaning that additional data is required before the drug can be marketed. ❋ Unknown (2007)
Last October, the FDA sent an "approvable" letter to Cephalon for the pediatric use of Sparlon pending a March 23, 2006, meeting of the Psychopharmacologic Drugs Advisory Committee to review the drug's approval. ❋ Unknown (2006)
In late December, Alkermes and marketing partner Cephalon received an "approvable" letter from the U.S. Food and Drug Administration. ❋ Unknown (2006)
Federal health regulators said the five- and ten-milligram doses of the drug were "approvable" but rejected the 15-milligram dose. ❋ Unknown (2006)
Second, a drug may be declared "approvable," meaning that minor concerns must be worked out between the FDA and the sponsor prior to full approval. ❋ Unknown (2009)
During the past three years, the company received three "approvable" letters from the federal agency, each of which requested additional information before the agency would grant final approval. ❋ Unknown (2009)
Significantly, all issues relating to the other elements of the regulatory package, notably the key Chemistry and Manufacturing Controls (CMC), Pre-clinical and Environmental Dossiers were cleared by the assessors and were thus deemed 'approvable'. ❋ Unknown (2009)
3M has received an "approvable" letter from the U.S. ❋ Unknown (2009)
MELA Sciences surged 1.75, or 55%, to 4.93, after the company received an approvable letter from the Food and Drug Administration for its MelaFind device, used to diagnose melanoma. ❋ Brendan Conway (2011)
Approve this or [youre] a [pansy] ❋ S Ecret (2020)
[You and I] have a [mutual] approvation on [golf]. ❋ Spartin1217 (2016)
John: Hey Z, what's your favorite color? Try not to do too much [approvaling] this time though.
Z: My favorite color is [blue]? And like, it has always been blue? [Blue] is the greatest color?
John: Yes Z, it is indeed blue. ❋ RobTheConqueror (2023)
PLEASE APPROVE THIS AND [ADD IT] ❋ Fynnster48 (2018)
Person 1: Who did you hear that "[that's what she said]" joke from? Was it [Micah]?
Person 2: Nah, it was John, [Micah's] WAY too Mormon Approved. ❋ MuffinMan794 (2011)
Built that [shed], the cats are [all over it] now it's [cat approved]. ❋ ElectricBananaMan (2019)
I think [my sack] was [shorted], man. That shit is not [Rabbi approved]. ❋ Catpoop5 (2010)
[Fake friend] usually are "[approval] [seekers]" Around people they are trying to impress. ❋ Butter Cups (2016)
I had to [courtesy approve] her friend request so I wouldn't look like a dick. She's friends with Monica and I can't be havin Monica thinkin I'm a dick, cause she gonna be [my baby momma] one day. [Gnome Sayin]? ❋ Paddywack (2011)
[I don't care] if my [boss] likes me, I'm not some [low-down] approval slut. ❋ ArabGoBoom (2010)
