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| T01-28 | Print Media: 301-827-6242 |
| July 12, 2001 | Consumer Inquiries: 888-INFO-FDA |
The Food and Drug Administration today published a guidance for industry explaining how the agency plans to handle oral levothyroxine sodium products that are being marketed without an approved application after August 14, 2001.
On August 14, 1997, FDA announced in the Federal Register (62 FR 43535) that orally administered levothyroxine sodium drug products are "new drugs" and that manufacturers who wish to continue marketing these products must submit a new drug application (NDA) for approval. The agency based its decision on a history of potency and stability problems with orally administered levothyroxine sodium products. The notice stated that after August 14, 2000, any unapproved levothyroxine sodium drug product on the market would be subject to regulatory action by FDA.
On April 26, 2000, FDA extended the deadline to August 14, 2001. As of July 2001, two levothyroxine sodium products have been approved by FDA to treat hypothyroidism. Unithroid, manufactured by Jerome Stevens Pharmaceuticals, was approved on August 21, 2000. Levoxyl, manufactured by Jones Pharma, was approved on May 25, 2001. Now that two products have been approved, FDA is issuing guidance regarding the transition of patients from unapproved to approved products.
Because there is no public health emergency that requires an immediate switch to the approved drugs, FDA has established a gradual phase out of distribution of the unapproved products to allow manufacturers of approved products to scale up to meet demand and to allow adequate time for patients and health care providers to make an orderly transition from unapproved to approved products.
On August 14, 2001, there will be two types of unapproved marketed levothyroxine sodium products: (1) those with NDAs that have been submitted to FDA and are under review and (2) those with no pending NDAs.
Under the phase out outlined in the guidance, manufacturers of unapproved oral levothyroxine sodium drug products with NDAs pending as of August 14, 2001, should reduce the distribution of these products according to an incremental reduction of average monthly distribution. This phase-out schedule is explained in the guidance. By August 14, 2003, all distribution of unapproved oral levothyroxine sodium products must cease.
Manufacturers of unapproved oral levothyroxine sodium drug products who do not have an NDA pending with the FDA by August 14, 2001, should cease distribution of their products by that date or they will be subject to regulatory action.
For more information, physicians and manufacturers may refer to the guidance
for industry, Levothyroxine Sodium Products Enforcement of August 14, 2001,
Compliance Date and Submission of New Applications, which can be found on
the FDA Web site (http://www.fda.gov/cder/guidance/4647fnl.htm).
Patients should consult their physicians regarding their choice of approved
levothyroxine sodium products.
Office of Public Affairs
Hypertext uploaded by tg 2001-JUL-11.