Medical Foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of a normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription.
Breckenridge has entered into a joint venture for the marketing and distribution of authorized generic versions of Pamlab's medical food products containing Metafolin®. The joint venture includes a sub-license from Pamlab to Breckenridge for exclusive patents applicable to Pamlab's medical foods such as Metanx®, Deplin®, CerefolinNAC® and Neevo DHA®.