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References
1.
21 USC §§ 355, 360; and 35 USC §§ 156, 271 (the Hatch—Waxman Amendments to the Federal Food, Drug and Cosmetic Act).
2.
Response to citizen petition, Docket Nos. 2004P-075/CP1 and 2004P-0261/CP1, 2nd July, 2004 , p. 2 , note 2.
3.
Response to citizen petition, Docket Nos. 2004P-075/CP1 and 2004P-0261/CP1, 2nd July, 2004 , p. 7 .
4.Response to citizen petition , Docket Nos. 2004P-075/CPI and 2004P-0261/CPI, 2nd July, 2004 , p. 12 .
5.
Response to Pfizer's citizen petition in Docket No. 2004P-0227/CP1.
6.
This citizen petition, in conjunction with the citizen petition relating to authorised generics, was calculated by the branded industry to limit a generics company's control over the 180-day exclusivity. The FDA ruled for the branded industry with respect to authorised generics, but for the generics industry with respect to authority to waive the exclusivity.