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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics |
For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP |
Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP |
Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG |
Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
CORTROPHIN-ZINC (NDA-009854)
(CORTICOTROPIN-ZINC HYDROXIDE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
10/05/2026 (SUPPL-13)
4 Contraindications
Additions and/or revisions underlined:
When any of the following conditions are present:
Cortrophin®-Zinc is contraindicated in patients with a history of hypersensitivity reaction to corticotropin or any of the inactive ingredients of Cortrophin®-Zinc. Reactions have included anaphylaxis and angioedema.
. . .
5 Warnings and Precautions
WARNINGS
Additions and/or revisions underlined:
Chronic administration of corticotropin may lead to adverse side effects which are not reversible. Corticotropin may only suppress symptoms and signs of chronic disease without altering the natural course of the disease. Cortrophin®-Zinc should not be administered for treatment until adrenal responsiveness has been verified with the route of administration which will be utilized during treatment, i.e. intramuscularly. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect. Hypersensitivity reactions including anaphylaxis and angioedema have been reported. Prolonged administration of corticotropin increases the risk of hypersensitivity reactions. Although the action of corticotropin is similar to that of exogenous adrenocortical steroids the quantity of adrenocorticoid may be variable. In patients who receive prolonged corticotropin therapy the additional use of rapidly acting corticosteroids before, during, and after an unusual stressful situation is indicated.
. . .
6 Adverse Reactions
Additions and/or revisions underlined:
. . .
Allergic reactions
Especially in those who have exhibited allergic responses to proteins; these responses may manifest themselves as skin reactions, dizziness, nausea, vomiting, anaphylaxis, including anaphylactic shock, respiratory compromise, angioedema, urticaria.
. . .