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Initial REMS approval: 02/2014 Most recent modification: 06/2014BLA 125390MYALEPT (metreleptin)Drug Class: Recombinant human leptin analog Manufactured for Amelia Pharmaceuticals LLC11800 Concord
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Recombinant human drug class refers to a class of drugs that are produced using recombinant DNA technology, involving genetic modification of living organisms to produce therapeutic proteins.
Manufacturers or sponsors of drugs falling under the class of recombinant human are required to file necessary documentation with regulatory authorities.
The filing process for drug class recombinant human typically involves submitting detailed information on the manufacturing process, quality control, safety, and efficacy of the drug.
The purpose of drug class recombinant human is to provide access to innovative therapies that are produced using advanced biotechnological methods, offering potential benefits in treating various diseases.
Information to be reported on drug class recombinant human includes manufacturing details, preclinical and clinical study data, indications, contraindications, adverse effects, and precautions.
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