New Drug Application definition

New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

New Drug Application means a new drug application, submitted to the FDA under 21 U.S.C. § 355(b) for authorization to market a drug in the United States.

New Drug Application or "NDA" means a new drug application, product license application or comparable regulatory submission to the FDA, the EMEA or an equivalent agency of a country in the Territory for permission to commence commercial sale of a Product.

Examples of New Drug Application in a sentence

• The safety and effectiveness of such products has to be proved to the regulatory agency through the New Drug Application (NDA) process before they can be marketed.

• EVERSANA supported the planned commercialization of apabetalone for the treatment of COVID-19 in the United States, Canada and any other countries agreed upon in the future as Emergency Use Authorization and/or a New Drug Application or equivalent if issued or approved in said countries.

• Notwithstanding anything to the contrary under this Agreement, all payments owed by Abpro per each Molecular under this Section 3.2 shall be due on the date such payment is due pursuant to the language below in this Section T2- (a) Within thirty (30) days of first approval by the NMPA of New Drug Application submitted by NJCTTQ for a NJCTTQ’s Royalty Bearing Product, NJCTTQ shall pay to Abpro USD $ [***].

• Until the Company fully satisfies its obligations, it is possible that the vendors could assert that the Company is in default and could pursue any remedies available to them.In 2021, the Company acquired certain intellectual property for: (a) $400,000 paid in cash and (b) a $600,000 milestone payment payable upon submission of a New Drug Application for apabetalone to the US Food and Drug Administration.

• The United States Food and Drug Administration (“FDA”) tentatively approved our New Drug Application (“NDA”) for YUTREPIA for the treatment of PAH in November 2021.

More Definitions of New Drug Application

New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the U.S.

New Drug Application means a new drug application or biologics license application filed in accordance with 21 CFR § 315.50 21 or CFR § 601.2 (as applicable) in the United States, or any similar application filed in any of the countries in the Territory under applicable Laws in such country for the approval for the marketing of a pharmaceutical or biological product, together with all subsequent submissions.

New Drug Application or “NDA” means an application submitted to the FDA pursuant to 21 USC Section 505(b), which contains complete details of the manufacture and testing of a new drug, for purposes of obtaining regulatory approval to market such new drug in the United States, for a particular indication, and also includes any Biologics License Application.

New Drug Application means the application required to be filed with the relevant Governmental Authority in any country in order to obtain approval to market commercially any Clopidogrel Product in such country.