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One of the relevant exclusivity periods applies to New Drug Applications (NDA) for approved products containing new chemical entities (NCEs), whereby an ANDA with a paragraph IV certification may not be submitted until four years after the NDA was approved (i.e., the NCE-1 date)
Jacobsen DW (1993)
Care 36 , S245S252 (2013)
Finally, the results of one randomized controlled trial in 601 patients with common forms of retinitis pigmentosa indicated that supplementation with 400 IU/day of synthetic vitamin E (equivalent to 180 mg/day of RRR --tocopherol) modestly but significantly accelerated the loss of retinal function compared to placebo (123)
Ballester, P., Cerd, B., Arcusa, R., Marhuenda, J., Yamedjeu, K., & Zafrilla, P
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