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FORTICAL

NDA

CALCITONIN SALMON RECOMBINANT | N021406 | UPSHER SMITH LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Upsher-Smith Laboratories, Inc. [Foley & Lardner, LLP] - Citizen Petition FDA-2008-P-0616 · 3 docket documents Upsher-Smith Laboratories, Inc., through Foley & Lardner LLP, filed this citizen petition on November 25, 2008, requesting that the FDA not accept for filing or approve any ANDA or 505(b)(2) NDA for synthetic or recombinant salmon calcitonin nasal spray products citing FORTICAL Nasal Spray as the re	505(q)	2008-12-02	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women NCT00620854	Phase 2	Completed	Tarsa Therapeutics, Inc.	24	2008-02 → 2008-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 10, 2014	SUPPL -22	View Letter (PDF)
Jul 10, 2014	SUPPL -17	View Letter (PDF)
Aug 17, 2011	SUPPL -16	View Letter (PDF)
Jun 26, 2009	SUPPL -8	View Letter (PDF)
Feb 12, 2007	SUPPL -7	View Letter (PDF)
May 1, 2006	SUPPL -3	View Letter (PDF)
Aug 19, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Aug 12, 2005

No patent or exclusivity listings for this strength.