Subject NDA definition

Subject NDA means New Drug Application (“NDA”) Number 215498, approved by the FDA on July 20, 2021 for BYLVAY (odevixibat) capsules and oral pellets for the treatment of pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC).
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Subject NDA means NDA No. 208627 approved on July 13, 2018 with respect to TPOXX® (tecovirimat) capsules, 200 mg, for the treatment of patients with human smallpox disease caused by variola virus.
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Subject NDA means NDA 205750 for CHOLBAM (Cholic Acid) Capsules, 50mg and 250mg.
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Examples of Subject NDA in a sentence

  • On the Closing Date, each of Buyer and Seller will submit to the FDA the separate notifications referred to in Section 3.2(f) and Section 3.2(g), respectively, as a submission to the Subject NDA, in each case under the cover letter substantially in the form attached hereto as Exhibit F.

  • Medical Officer, ODE III, DDDP David Kettl, MDClinical Team Leader, ODE III, DDDP From: Celestina Arowosegbe, Pharm.D.Regulatory Review OfficerOffice of Prescription Drug Promotion (OPDP) Subject: NDA 204286NAFTIN (naftifine hydrochloride) Gel, 2% for topical use Package Insert (PI) As requested in your consult dated October 1, 2012, OPDP has reviewed the draft PI for NAFTIN (naftifine hydrochloride) Gel, 2% for topical use.

  • Seller has initiated or will initiate marketing in the United States of the product approved under the Subject NDA within the 365-day period beginning on the date of the FDA approval of the Subject NDA.

  • Tolliver, Ph.D., Pharmacologist Controlled Substance Staff Subject: NDA 204-031, COV795 (also called NMK795) (Oxycodone HCl andAcetaminophen (b) (4) Tablets)(b) (4)Indication: Management of acute painDosages: 7.5 mg Oxycodone HCl / 325 mg Acetaminophen (APAP)Sponsor: Mallinckrodt Inc.

  • Freed, Ph.D. Supervisory Pharmacologist Subject: NDA 210-365 (cannabidiol, Epidiolex) NDA 210-365 was submitted by the sponsor (GW Research Ltd.) on October 27, 2017, for cannabidiol for the adjunctive treatment of seizures in patients (≥2 years of age) with Lennox Gastaut or Dravet Syndrome.

  • Shenee Toombs, Regulatory Review Officer (OPDP)CC: Olga Salis, Senior Regulatory Health Project Manager (OPDP) Michael Wade, Regulatory Health Project Manager (OPDP) Subject: NDA 207233OPDP labeling comments for Vivlodex (meloxicam) capsules, for oral use Labeling Review OPDP has reviewed the proposed package insert (PI) and carton/container labeling for Vivlodex (meloxicam) capsules, for oral use (Vivlodex) that was submitted for consult on May 11, 2015.

  • Jones, Regulatory Review Officer Office of Prescription Drug Promotion (OPDP) Subject: NDA 206073OPDP labeling comments for GLYXAMBI® (empagliflozin and linagliptin) tablets, for oral useOPDP has reviewed the proposed draft prescribing information (PI) and carton container labels for GLYXAMBI® (empagliflozin and linagliptin) tablets, for oral use (Glyxambi) submitted for consult on January 6, 2015.

  • Jones, Regulatory Review Officer Office of Prescription Drug Promotion (OPDP) Subject: NDA 206111OPDP labeling comments for SYNJARDY ® (empagliflozin and metformin hydrochloride) tablets, for oral use OPDP has reviewed the proposed draft labeling for SYNJARDY® (empagliflozin and metformin hydrochloride) tablets, for oral use (Synjardy) submitted for consult on July 15, 2015.

  • We agree to FDA’s proposals below Peter DiRomaHead of Regulatory Affairs and Quality Assurance Melinta Therapeutics, Inc.Lincolnshire, IL From: Rivera, Luz E (CDER) [mailto:Luz.E.Rivera@fda.hhs.gov]Sent: Wednesday, April 19, 2017 7:25 AMTo: Peter Di Roma Cc: Izadi, Fariba Subject: NDA 208610 INFORMATION REQUEST Good morning Mr. DiRoma: Please refer to your New Drug Applications (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Baxdela (Delafloxacin meglumine), Tablet.

  • Subject: NDA 207968 Jadenu Sprinkle/Revised FDA Proposed Labeling/Due 05.15.17Date: Friday, May 12, 2017 11:59:01 AMAttachments: NDA 207968 revised USPI 05122017.doc Dear Please see attached the revised draft of the PI for NDA 207968, Jadenu Sprinkle.


More Definitions of Subject NDA

Subject NDA means New Drug Application (“NDA”) Number 213793, approved by the FDA on November 25, 2020 for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
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Subject NDA means NDA 206488 for Exondys 51 (eteplirsen) Injection, 50mg per mL.
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Subject NDA means NDA Number 215904, approved by the FDA on March 18, 2022 for the use of Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients 2 years of age and older.
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Related to Subject NDA

  • 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.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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:

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • ANDA means Abbreviated New Drug Application.

  • Subsurface tracer study means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.

  • Study Subject an individual who participates in the Study, either as a recipient of the Investigational Product (defined below) or as a control. Subjekt studie: jednotlivec, který se účastní Studie, buď jakožto příjemce Hodnoceného léčiva (ve smyslu níže uvedené definice) nebo jako kontrolní subjekt.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.