NDA Approval definition

NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

NDA Approval means the receipt of notice from the relevant US Regulatory Authority that an NDA for a Licensed Product has met all the criteria for marketing approval.

NDA Approval means the Approval of an NDA by the FDA for the applicable Product in the U.S.

Examples of NDA Approval in a sentence

• At such time as Licensed Product of LICENSEE (or its Affiliates or sublicensees) firstachieves NDA Approval from the FDA and/or EMEA, as described below, LICENSEE will pay to LICENSOR the milestone payment specified below.

• The following Operating Plan Targets have been achieved to schedule during the period:• D021: Competition: Obtain NDA Approval for the PBO Competition Transition Plan;• D028: Unirradiated Fuels Characterisation Facility: Complete the facility Hazard and Operability Studies (HAZOPs) and Preliminary Safety report (PSR).All other in-year Operating Plan Targets remain on schedule with the exception of the following:• CT D001: Bulk NaK Destruction at Dounreay Fast reactor (DFR).

• United States Government Regulation NDA Approval Processes In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations.

• As between the Parties, Evoke shall own all right, title and interest in and to (a) all Regulatory Documentation concerning the Product and all information contained therein and (b) all regulatory approvals made or granted with respect to the Product, including any NDA Approval.

• Response: Torrent admits that in the NDA Approval letter dated November 8, 2013, the FDA stated, “This new drug application provides for the use of Aptiom (eslicarbazepine actetate) 200mg, 400mg, 600mg, and 800mg tablets for adjunctive therapy in the treatment of partial- onset seizures in patients with epilepsy 18 years and older.” Otherwise, the November 8, 2013 NDA Approval letter speaks for itself and Torrent denies any allegations inconsistent therewith.

More Definitions of NDA Approval

NDA Approval means approval by the FDA for marketing and sale of a Product in the United States, including any applicable pricing, final labeling or reimbursement approvals, as applicable.

NDA Approval means receipt of a written letter of approval by the FDA of an NDA pursuant to 21 C.F.R. § 314.105.

NDA Approval means the approval by the competent registration body for a given country of an NDA.

NDA Approval means the final approval to market the Product by the FDA as defined under the Act.

NDA Approval means an NDA approved by the FDA or EMEA that is not conditioned on any other event (or if NDA Approval is conditioned upon an event, then the occurrence of that event), provided, however, such other events shall specifically not include FDA or EMEA requirements to conduct post marketing studies and any requirement for such post marketing studies shall not be deemed to delay the Final Approval.

NDA Approval means written approval by the FDA of an NDA pursuant to 21 C.F.R. Part 314.105 and satisfaction of related applicable FDA requirements, if any, and any conditions of approval set forth in such writing.

NDA Approval means the approval of a NDA by FDA for Commercialization of the Product.