Cubicin definition

Cubicin means that certain pharmaceutical compound known as daptomycin in prescription form for injection that has received Regulatory Approval from the FDA to be marketed in the Territory under the Cubist Trademark Cubicin. ***Confidential Treatment Requested
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Examples of Cubicin in a sentence

  • A separate ranking of manufacturers of generic antibiotics ranks Mylan, Cipla, and Fresenius Kabi Global highest, with Entasis Therapeutics, a US company developing new treatments for resistant gram-negative infections ranks first among biotech companies.New antibiotic developments can be “block-busters”: Cubicin sales of 2016 USD 1.087m37 met market forecasts following the acquisition of Cubist Inc by Merck & Co in November 2014 in a deal reported as USD 8.4bn.

  • Since 2003 he has worked at Cubist Pharmaceuticals, where he helped lead the approval process for Cubicin at the FDA and is now Senior Vice President, Scientific Affairs.

  • Cubist sells its daptomycin formulation under the trade name Cubicin.

  • Two antibiotic drugs– Orbactiv (oritavancin) and Cubicin (daptomycin) – spent 17.2 years and 16.9 years, respectively, in clinical testing.

  • Figure 4.4.2 Discovery of New Classes of Antibiotics(Sources: Nordberg P et al, 2004, Levy SB, 2002, Singh MP, 2000) xv The growth of the antibiotic market peaked in 2003 at 11% from the previous year, due to the launch of Cubicin.

  • This decentralised procedure concerns a generic application claiming essential similarity with the innovator product Cubicin 350 mg and 500 mg powder for solution for injection or infusion which has been registered in the EEA by Merck Sharp & Dohme B.V. since 19 January 2006 through a centralised procedure (EU/1/05/328).

  • Cubicin is a well-known medicinal product with an established favourable efficacy and safety profile.

  • The following are some examples: • Daptomycin (Cubicin) of Novartis was launched overseas on 13-9-2003 and approved in India on 28-1-2008 after a gap of over four years.

  • It’s also worth noting that the Prescribing Information for Cubicin warns that ‘ anaphylaxis/hypersensitivity reactions have been reported with the use ofantibacterial agents, including Cubicin’.

  • Sold under the tradename of Cubicin (Cubist Pharmaceuticals) it is used specifically against multiply resistant gram positive organisms.

Related to Cubicin

  • Encapsulation means the application of an encapsulant.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Encapsulant means a substance that forms a barrier between lead-based paint and the environment using a liquid-applied coating (with or without reinforcement materials) or an adhesively bonded covering material.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Radionuclide means a radioactive element or a radioactive isotope.

  • Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.

  • Semisolid means a product that, at room temperature, will not pour, but will spread or deform easily, including but not limited to gels, pastes, and greases.

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • Precursor means any chemical reactant which takes part at any stage in the production by whatever method of a toxic chemical. This includes any key component of a binary or multicomponent chemical system.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Isomer means all enantiomers and diastereomers.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Electrostatic spray means a method of applying a spray coating in which opposite electric charges are applied to the substrate and the coating. The coating is attracted to the substrate by the electrostatic potential between them.

  • Cyanoacrylate adhesive means any adhesive with a cyanoacrylate content of at least 95% by weight.

  • Inert ingredient means an ingredient which is not an active ingredient.

  • Geothermal fluid means water in any form at temperatures greater than 120

  • Density means the permitted number of dwelling units per

  • Nitrogen oxides means nitric oxide and nitrogen dioxide, expressed as nitrogen dioxide (NO2);

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Hydrofluorocarbons means compounds that only contain hydrogen, fluorine, and carbon.

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.