April 26, 2000

In a letter dated April 26, 2000 to Synthroid manufacturer Knoll Pharmaceuticals, the FDA makes it clear that the August 14, 2001 deadline is a firm one.

Says the letter: "The FDA denies Knoll's request to set a date by which NDAs must be submitted rather than approved...We believe the additional year the Agency is allowing for all sponsors to obtain NDA approval grants in substantial part Knoll's request for additional time to comply with the 1997 notice.

Knoll had asked the FDA to "modify the schedule in the 1997 notice to state a date by which NDAs must be received by the Agency, not a date by which they must be approved." Knoll requested that the Agency set a date for receipt of applications that is at least 6 months after FDA rules on Knoll's GRAS/E petition and the courts have completed their review of FDA's decision, and at least 6 months after FDA has declared that all applications filed pursuant to the 1997 notice will be filed, reviewed and approved (if warranted)..."

The letter also states that "Knoll further requests that FDA confirm that it will allow Knoll at least 60 days to supplement its GRAS/E petition after Knoll receives a complete response to its FOIA request. Finally, Knoll asks FDA to declare that any all application for levothyroxine sodium products submitted under the 1997 notice will be filed, reviewed, and approved (if warranted) as NDAs..."

To read the full letter, download the Portable Document Format (PDF) version at the FDA website: http://www.fda.gov/ohrms/dockets/dailys/00/may00/050400/pav0001.pdf