Request that FDA refuse to accept any submissions by Lannett Inc. in furtherance of its application submitted under the 21 U.S.C. § 355(b)(2) approval pathway (a “505(b)(2)”) for cocaine hydrochloride, 4% and 10%. Any such submissions by Lannett are barred by the new chemical entity exclusivity arising from FDA’s approval of Genus’s NDA 209963 under Section 505(c)(3)(E)(ii) of the FDCA.
Citizen Petition Genus Lifesciences, Inc. (“Genus”), Lannett Company, Inc. (“Lannett”) in K&L GATES LLP CDER cocaine hydrochloride, 4% and 10%. new drug application (“NDA”) 209963 under Section 505(c)(3)(E)(ii) of the FDCA for cocaine hydrochloride nasal solution new chemical entity (“NCE”) exclusivity under 21 U.S.C. § 355(c)(3)(E)(ii),
2019-05-16
FDA-2019-P-0538-0025
04:00:00
https://api.regulations.gov/v4/comments/FDA-2019-P-0538-0025
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Genus Reply Comment to Citizen Petition