FDA.reportPublic FDA data

Application 022504

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AXIRONTESTOSTERONESOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022504-001AXIRONTESTOSTERONE30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION, METERED / TRANSDERMALRLD2010-11-23

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022504-00189935202026-06-02U-13902015-04-09
N022504-00191801942026-06-02U-13902015-12-03
N022504-00184193072027-02-26U-13862013-04-30
N022504-00188078612027-02-26U-1563Drug product2014-09-10
N022504-00192895862027-02-26U-13902016-04-19
N022504-00184359442027-09-27U-1390

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEEncube Ethicals, Inc.ca5d4865-356b-45e7-b603-fe299e450abc2026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
TESTOSTERONETESTOSTERONEEncube Ethicals, Inc.44a04f66-fd2a-45c7-934e-8f14c023ce142026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONENorthstar Rx LLC65981b8a-d5cc-1964-7eac-a07f032c25712026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEXiromed, LLC28e8d504-5073-1d78-f351-bcb7c5188ee62026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.29c8846f-121c-4958-9e03-3bd271c215582026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONELupin Pharmaceuticals, Inc.61387416-510d-40c5-9e2d-24bfb7f56d082026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEBryant Ranch Prepackc6c0a39e-0e75-4356-a052-c26c30c76b262025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEActavis Pharma, Inc.5834d34f-839d-412c-b74c-da1dad2cfa882025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEActavis Pharma, Inc.e18b4495-c5a3-4a7f-9636-1793207843812025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEBryant Ranch Prepack6c7d2dec-6492-4d53-b110-61ffeae9ee612025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
testosteroneTESTOSTERONENorthstar Rx LLC2d55b825-8eab-4091-bdf2-9c52d111b8eb2025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltd54fcdcb9-fb0e-4164-9e51-f2a5feae32172025-08-31Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEStrides Pharma Science Limitedee54c393-bcfe-4a52-b7b3-1da8750f35d92025-08-22Boxed warning, Warnings, Adverse reactionsName fallback
TestosteroneTESTOSTERONEActavis Pharma, Inc.4f3c2c0a-7dab-4b50-9cae-869c3c2a84982025-08-01Boxed warning, Warnings, Adverse reactionsName fallback
testosteroneTESTOSTERONEBryant Ranch Prepack9e10a37a-9c40-456b-a362-2fa8eae31e842025-07-29Boxed warning, Warnings, Adverse reactionsName fallback
Natesto nasal gelTESTOSTERONEAcerus Pharmaceuticals Corporationdea6bed1-eaca-11e3-ac10-0800200c9a662025-07-22Warnings, Adverse reactionsName fallback
TestopelTESTOSTERONEEndo USA, Inc.03b9c0b1-5884-11e4-8ed6-0800200c9a662025-07-17Warnings, Adverse reactionsName fallback
TestimTESTOSTERONEEndo USA, Inc.9f2aae1f-898d-4955-be31-678e0cf853952025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
VogelxoTESTOSTERONEUpsher-Smith Laboratories, LLC2dd150f6-cdfd-4d51-8888-12b288f262622025-07-14Boxed warning, Warnings, Adverse reactionsName fallback
TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals Inc.e39289aa-681c-47ec-9461-52e7f17e5d712025-07-14Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to topical testosterone products [ see Warnings and Precautions ( 5.2 ) ]. Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution [see Dosage and Administratio n ( 2.2 ) and Warnings and Precautions ( 5.2 )]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 ) and Pati ent Counselling Information ( 17 ) ]. WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to topical testosterone products ( 5.2 ). Children should avoid contact with unwashed or unclothed application sites in men using Testosterone Topical Solution ( 2.2 , 5.2 ). Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.2 , 17 ).

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ( 5.1 ) Avoid unintentional exposure of women or children to Testosterone Topical Solution. Secondary exposure to testosterone can produce signs of virilization. Testosterone Topical Solution should be discontinued until the cause of virilization is identified. ( 2.2 , 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE. ( 5.4 ) Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. ( 5.5 ) Exogenous administration of testosterone may lead to azoospermia. ( 5.8 ) Edema with or without congestive heart failure, may be a complication in patients with pre existing cardia, renal or hepatic disease. ( 5.10 ) Sleep apnea may occur in those with risk factors. ( 5.12 ) Monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically. ( 5.1 , 5.3 , 5.9 , 5.13 ) Testosterone Topical Solution is flammable until dry. ( 5.16 ) 5.1 Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Patients treated with Androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It would be appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices. [See Contraindications ( 4 )]. 5.2 Potential for Secondary Exposure to Testosterone Cases of secondary exposure to testosterone in children and women have been reported with topical testosterone products applied to the abdomen or upper arms, including cases of secondary exposure resulting in virilization of children. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone. In a few cases, howev...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 4%) are skin application site reactions, increased hematocrit, headache, diarrhea, vomiting and increased serum PSA. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Pvt. Ltd. at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov.medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Hypogonadal Men Table 2 shows the treatment emergent adverse reactions that were reported by either >4% of 155 patients in a 120 day, Phase 3 study or by > 4% of 71 patients who continued to use Testosterone Topical Solution for up to 180 days. These data reflect the experience primarily with a testosterone dose of 60 mg, which was taken by all patients at the start of the study and was the maintenance dose for 97 patients. However, the doses used varied from 30 mg to 120 mg. Table 2: Adverse Reactions Seen With the Use of Testosterone Topical Solution in either the 120 Day Clinical Trial or in the Extension to 180 Days (>4%) Event 120 Days (155 Patients) 180 Days (71 Patients) Application Site Irritation 11 (7%) 6 (8%) Application Site Erythema 8 (5%) 5 (7%) Headache 8 (5%) 4 (6%) Hematocrit Increased 6 (4%) 5 (7%) Diarrhea 4 (3%) 3 (4%) Vomiting 4 (3%) 3 (4%) PSA Increased 2 (1%) 3 (4%) Other less common adverse reactions reported by at least 2 patients in the 120 day trial included: application site edema, application site warmth, increased hemoglobin, hypertension, erythema (general), increased blood glucose, acne, nasopharyngitis, anger and anxiety. Other less common adverse reactions reported in fewer than 1% of patients in the 120 day trial included: asthenia, affect lability, folliculitis, increased lacrimation, breast tenderness, increased blood pressure, increased blood testosterone, neoplasm prostate and elevated blood cell count. During the 120 day trial one patient discontinued treatment because of lability/anger which was considered possibly related to the Testosterone Topical Solution administration. During the 120 day clinical trial there was an increase in man PSA values of 0.13 ± 0.68 ng/mL from baseline. At...

adverse reactions table

Table 2: Adverse Reactions Seen With the Use of Testosterone Topical Solution in either the 120 Day Clinical Trial or in the Extension to 180 Days (>4%)Event120 Days (155 Patients)180 Days (71 Patients)Application Site Irritation 11 (7%) 6 (8%) Application Site Erythema 8 (5%) 5 (7%) Headache 8 (5%) 4 (6%) Hematocrit Increased 6 (4%) 5 (7%) Diarrhea 4 (3%) 3 (4%) Vomiting 4 (3%) 3 (4%) PSA Increased 2 (1%) 3 (4%)

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48988SUPPL2017-07-14
48982SUPPL2017-07-14
48981SUPPL2017-07-14
47127SUPPL2017-02-07
47100SUPPL2017-02-06
46988SUPPL2017-01-27
45744SUPPL2016-11-01
45678SUPPL2016-10-27
29792SUPPL2015-05-13
17653SUPPL2015-05-13
42542SUPPL2014-07-07
38770SUPPL2014-06-23
7465SUPPL2014-06-23
29791SUPPL2011-12-28
17652SUPPL2011-12-23
44763ORIG2011-09-16
22038ORIG2011-09-16
44506ORIG2011-04-04
29790SUPPL2011-04-04
17651SUPPL2011-04-01
29789ORIG2010-11-29
38769ORIG2010-11-23