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 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.

Examples of NDA Approval in a sentence

• Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory.

• In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s).

• Without limiting the foregoing, as owner of the NDA Approval for the Initial POZEN Product, Licensee will be the sole owner of all data exclusivity protection related to the Initial POZEN Product in the Territory as provided by Applicable Law.

• Without limiting any other obligation of the Seller under this Agreement, the Seller shall cooperate with the Acquiror in the Acquiror’s efforts to obtain Evamist NDA Approval, including providing to the Acquiror all relevant data, information and material reasonably requested by the Acquiror which the Acquiror shall not disclose to any third Person or use except solely and to the extent necessary for prosecuting the Evamist NDA and obtaining the Evamist NDA Approval.

• The Acquiror agrees and acknowledges that, following the Closing until the Evamist NDA Approval Date, the Seller shall have the right to use any and all Purchased Assets solely and to the extent necessary for carrying out the Seller’s right hereunder to prosecute the Evamist NDA and obtain the Evamist NDA Approval.

More Definitions of NDA Approval

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

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

NDA Approval means the first approval by the FDA of a New Drug Application for the Product.

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 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 approval from the Japanese Ministry of Health and Welfare or other applicable regulatory body, as the case may be, of a New Drug Application which authorizes or allows the import to or manufacture in the Territory of and sale in the Territory of a Venture Product.