NDA Approval Letter definition

NDA Approval Letter means the NDA approval letter dated July 13, 2018 from the Department of Health and Human Services to Seller, Reference ID: 4291064, approving the Subject NDA and granting the Priority Review Voucher, attached hereto as Exhibit A.
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NDA Approval Letter means the NDA approval letter dated July 20, 2021 from the FDA to Seller, Reference ID 4828760, regarding approval of the Subject NDA and granting the Priority Review Voucher, attached hereto as Exhibit B.
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NDA Approval Letter means the New Drug Application (“NDA”) approval letter dated June 25, 2018 from the Department of Health and Human Services to Seller, Reference ID: 4282447, regarding NDA 210365 for Epidiolex® (cannabidiol) 100 mg/mL oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older, and granting the Priority Review Voucher. A copy of the NDA Approval Letter is attached hereto as Exhibit A.
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Examples of NDA Approval Letter in a sentence

  • See Ex. 29, Skyla NDA Approval Letter; Ex. 30, Liletta NDA Approval Letter.

  • Judicial Notice, Ex. A, NDA Approval Letter (“NDA Approval Letter”), ECF No. 26-1.

  • Moreover, as explained above, Spectrum experienced a longer delay – approximately one third longer – than J&J did between the time FDA sent the initial NDA Approval Letter and the time the Agency accepted the proposed trade names.

  • Between February 17, 2012 –- when Korlym was approved, see NDA Approval Letter 7 -- and February 2019 -- when Pietrantoni was taken off Korlym, see Compl.

  • Seller has provided to Buyer true and complete copies of the NDA Approval Letter and all other written communications between Seller and the FDA regarding the Priority Review Voucher.

  • There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the NDA Approval Letter or Section 565A of the FDC Act.

  • NDA Approval Letter for New Drug Application (NDA) 205551, Triumeq (abacavir, dolutegravir, and lamivudine), fixed-dose combination tablets, 600/50/300 mg.August 22, 2014.

  • With respect to the FDA approval processes, Corcept and Optime request that the Court take judicial notice of five exhibits:• The FDA’s February 17, 2012, NDA Approval Letter for Korlym• Korlym’s February 17, 2012, label• Korlym’s October 25, 2016, label• The FDA’s Center for Drug Evaluation and Research Medical Review(s) relating to Corcept’s NDA• Corcept’s February 15, 2011, cover letter regarding submission of its NDA for Korlym Defs.’ Req.

  • The Client never has the right to set off (alleged) claims against CurTec against debts to CurTec.

  • To Seller’s knowledge, there is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the NDA Approval Letter or Section 524 of the FDC Act, as interpreted by the FDA in the Tropical Disease Priority Review Vouchers, Guidance for Industry issued in October 2016.


More Definitions of NDA Approval Letter

NDA Approval Letter means the new drug application approval letter dated August 6, 2020 from the FDA approving NDA 213464 for LAMPITTM (nifurtimox) 30 mg and 120 mg tablets and granting the Priority Review Voucher. A copy of the NDA Approval Letter is attached hereto as E xhibit A.
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NDA Approval Letter means the new drug application approval letter dated August 6, 2020 from the FDA approving NDA 213464 for LAMPITTM (nifurtimox) 30 mg and 120 mg tablets and granting the Priority Review Voucher. A copy of the NDA Approval Letter is attached hereto as Exhibit A.
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Related to NDA Approval Letter

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

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

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Disclosure Statement Approval Order means the Final Order approving, among other things, the adequacy of the Disclosure Statement pursuant to section 1125 of the Bankruptcy Code.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Equityholder pursuant to the terms of the First Tier Purchase and Sale Agreement and by the Equityholder to the Borrower pursuant to the terms of the Second Tier Purchase and Sale Agreement and the Assignments by which the Transferor effects such conveyance.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities set out in Schedule C hereto;

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Agent, desirable to perfect the security interests purported to be created by each Security Agreement, each Pledge Agreement and each Mortgage.

  • Preliminary Approval Order means the proposed Order Granting Preliminary Approval of Class Action Settlement, Approving Form and Manner of Notice, and Setting Date for Hearing on Final Approval of Settlement, which, subject to the approval of the Court, shall be substantially in the form attached hereto as Exhibit A.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: