DALFAMPRIDINE | A206646 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Acorda Therapeutics, Inc FDA-2016-P-4585 · 3 docket documents Acorda Therapeutics, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA carefully review any abbreviated new drug application referencing AMPYRA (dalfampridine) Extended Release Tablets to ensure adequate identification and quali | 505(q) | 2016-12-28 | Open | Acorda Therapeutics, Inc |
Citizen Petition From Acorda Therapeutics FDA-2014-P-2193 · 14 docket documents Acorda Therapeutics filed this petition on December 12, 2014 requesting that the FDA establish more stringent bioequivalence criteria for abbreviated new drug applications under section 505(j) for generic versions of dalfampridine citing Acorda's Ampyra as the reference listed drug, including requir | 505(q) | 2014-12-15 | Denied | Acorda Therapeutics |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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