Webpursuant to section 505(b(2) of the FDCA (S-065) for Thyrogen (thyrotropin alfa) for injection. These Prior Approval sNDAs provide for the following changes to the Thyrogen labeling: • S-063: updates prescribing information (PI) Section 8 USE IN SPECIFIC ... the FDA automated drug registration and listing system (eLIST), as described at WebThyrogen is supplied as a sterile, non-pyrogenic, white to off-white lyophilized product, intended for intramuscular (IM) administration after reconstitution with Sterile Water for …
Drug Safety and Availability FDA
WebDescription. This standard provides for a mechanism for classifying all drugs from the Investigational New Drug (IND) stage of development onward. Source. In process - CDER Drug Classification... WebTHYROGEN is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total … pitagora software
Thyrogen THYROTROPIN ALFA .9 mg/mL Genzyme Corporation
WebTHYROGEN is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. : WebDec 17, 2007 · The FDA has approved a supplemental indication for Genzyme’s Thyrogen to be used in combination with radioiodine to destroy remaining tissue in patients who … WebApr 13, 2024 · Drug questions email: [email protected]. See also: Drug Registration and Listing Instructions National Drug Code Directory Data Files. U.S Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Division of Data Management … pitagoras software