NEVANAC nepafenac 1 mg/mL Suspension/ Drops — NDC 82667-500-03 (Billing 82667-0500-03)
This is a package of NEVANAC nepafenac 1 mg/mL Suspension/ Drops from Harrow Eye, LLC, marketed since Jan 2025 and currently FDA-listed; retail pharmacies pay about $104.71 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 82667-500-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 82667 labeler · 500 product · 03 package
- Package marketed since
- Jan 1, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 8266750003 2
- Medicaid fills, this package
- 218 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059670
- GCN: 25416
- GPI-14 (Medi-Span): 86805050001820
- HICL (First Databank): 033195
- AHFS class code: 52:08.20.00
- RxCUI (RxNorm): 578044
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- It treats pain and inflammation after cataract surgery. Ilevro 0.3% is the product described for this use.
- With Ilevro 0.3%, you put one drop in the eye once a day, starting the day before surgery. You keep going on surgery day and for the first 2 weeks afterward, with an extra drop sho...
- Yes, it can be used with other eye medicines such as beta-blockers and dilating drops. Just wait at least 5 minutes between different drops.
- No. Ilevro 0.3% should not be used while wearing contact lenses.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nepafenac — tap one for details:
Nepafenac may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $104.707 | $314.12 / 3 ml |
| Medicaid paysCMS SDUD · 12 mo | $107.04 | $321.11 / 3 ml |
| Medicare drug plans payPart D · Q2 2026 | $108.79 | $326.37 / 3 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 82667-0500-03 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 3 mL in 1 BOTTLE, PLASTIC | 2025-01-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nevanac 1 mg/mLthis 82667-0500-03 | Harrow | 1 bottle | $104.707 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7834059 ↗ | Method of use | U-1095 | Jan 31, 2027 |
Is there a generic version of NEVANAC 0.1% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 9, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Nepafenac Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII Y27PUL9H56
Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Harrow Eye, LLC labeler code 82667
- Byooviz ranibizumab-nuna 10 mg/mL Injection, Solution NDC 82667-018-05
- BYQLOVI clobetasol propionate .5 mg/mL For Suspension NDC 82667-021-00
- Maxitrol neomycin sulfate, polymyxin b sulfate and dexamethasone 3.5 mg/mL; 10000 [USP'U]/mL; 1 mg/mL Suspension NDC 82667-100-05
- IOPIDINE 1% apraclonidine hydrochloride ophthalmic solution 10 mg/mL Solution/ Drops NDC 82667-200-01
- IHEEZO chloroprocaine hydrochloride ophthalmic gel 24 mg/800mg Gel NDC 82667-300-00
- ILEVRO nepafenac 3 mg/mL Suspension/ Drops NDC 82667-400-03
- MAXIDEX dexamethasone 1 mg/mL For Suspension NDC 82667-600-05
- VIGAMOX moxifloxacin hydrochloride 5 mg/mL Solution/ Drops NDC 82667-700-03
- TRIESENCE triamcinolone acetonide 40 mg/mL Injection, Suspension NDC 82667-800-01
- VEVYE cyclosporine ophthalmic solution 1 mg/mL Solution/ Drops NDC 82667-900-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE NEVANAC ® 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION One drop of NEVANAC should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. ( 2.1 )
2.1Recommended Dosing One drop of NEVANAC 0.1% should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. Shake the container well prior to dosing.
2.2Use With Other Topical Ophthalmic Medications NEVANAC 0.1% may be administered in conjunction with other topical ophthalmic medications, such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic suspension 0.1% 3 mL in a 4 mL bottle Sterile ophthalmic suspension 0.1% 3 mL in a 4 mL bottle ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS NEVANAC 0.1% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS). ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Increased bleeding time due to interference with thrombocyte aggregation ( 5.1 ) Delayed Healing ( 5.2 ) Corneal effects, including keratitis ( 5.3 )
5.1Increased Bleeding Time With some NSAIDs, including NEVANAC 0.1%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that NEVANAC 0.1% be used with caution in patients with known bleeding tendencies, or who are receiving other medications, which may prolong bleeding time.
5.2Delayed Healing Topical NSAIDs, including NEVANAC 0.1%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
5.3Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including NEVANAC 0.1%, and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight threatening.
Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.
5.4Contact Lens Wear NEVANAC ® 0.1% should not be administered while using contact lenses.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of labeling: Increased Bleeding Time [see Warnings and Precautions (5.1) ] Delayed Healing [see Warnings and Precautions (5.2) ] Corneal Effects [see Warnings and Precautions (5.3) ] Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation. These reactions occurred in approximately 5% to 10% of patients.
Other ocular adverse reactions occurring at an incidence of approximately 1% to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing, and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure. Non-ocular adverse reactions reported at an incidence of 1% to 4% included headache, hypertension, nausea/vomiting, and sinusitis.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses greater than or equal to 10 mg/kg were associated with dystocia, increased post-implantation loss, reduced fetal weights and growth, and reduced fetal survival.
Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, NEVANAC 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Non-Teratogenic Effects Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of NEVANAC 0.1% during late pregnancy should be avoided.
8.3Nursing Mothers Nepafenac is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NEVANAC 0.1% ophthalmic suspension is administered to a nursing woman.
8.4Pediatric Use The safety and effectiveness of NEVANAC 0.1% in pediatric patients below the age of 10 years have not been established.
8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 260 and 2400 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 80 and 680 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses greater than or equal to 10 mg/kg were associated with dystocia, increased post-implantation loss, reduced fetal weights and growth, and reduced fetal survival.
Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, NEVANAC 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Non-Teratogenic Effects Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of NEVANAC 0.1% during late pregnancy should be avoided.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of NEVANAC 0.1% in pediatric patients below the age of 10 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, an NSAID. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
12.3Pharmacokinetics Low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post dose, respectively, following bilateral topical ocular 3 times-daily dosing of nepafenac ophthalmic suspension, 0.1%. The mean steady-state C max for nepafenac and for amfenac were 0.310 ± 0.104 ng/mL and 0.422 ± 0.121 ng/mL, respectively, following ocular administration. Nepafenac at concentrations up to 300 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4).
Therefore, drug-drug interactions involving CYP-mediated metabolism of concomitantly administered drugs are unlikely. Drug-drug interactions mediated by protein binding are also unlikely.
🧬 Mechanism of Action ▾
12.1Mechanism of Action After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, an NSAID. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING NEVANAC ® 0.1% is supplied in a white, oval, low density polyethylene dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented in an overwrap, which provides tamper evidence to the package. Tamper evidence for the 3 mL fill is provided with a shrink band around the closure and neck area of the package.
3 mL in a 4 mL bottle……………………………………………………………………………NDC 82667-500-03 Storage: Store at 2°C to 25°C (36°F to 77°F).
📋 Description ▾
11 DESCRIPTION NEVANAC ® 0.1% is a sterile, topical NSAID prodrug for ophthalmic use. Each mL of NEVANAC 0.1% contains 3 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C 15 H 14 N 2 O 2 .
The structural formula of nepafenac is: Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28 g/mol. NEVANAC, 0.1% is supplied as a sterile, aqueous suspension with a pH approximately of 7.4.
The osmolality of NEVANAC 0.1% is approximately 305 mOsm/kg. Each mL of NEVANAC 0.1% contains: Active: nepafenac 0.1%. Inactives: benzalkonium chloride 0.005% (preservative), carbomer 974P, edetate disodium, mannitol, purified water, USP, sodium chloride, sodium hydroxide and/or hydrochloric acid to adjust pH, and tyloxapol.
The structural formula of nepafenac
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Slow or Delayed Healing Advise the patient of the possibility that slow or delayed healing may occur while using NSAIDs [see Warnings and Precautions (5.2) ] . Avoiding Contamination of the Product Advise the patient to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. Contact Lens Wear Advise the patient that NEVANAC 0.1% should not be administered while wearing contact lens [see Warnings and Precautions (5.4) ] . Intercurrent Ocular Conditions Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of the multi-dose container [see Warnings and Precautions (5.1) ] .
Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart [see Dosage and Administration (2.2) ] . Shake Well Before Use Advise the patient to shake the container well [see Dosage and Administration (2.1) ] .
🍼 Nursing Mothers ▾
8.3Nursing Mothers Nepafenac is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NEVANAC 0.1% ophthalmic suspension is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Low but quantifiable plasma concentrations of nepafenac and amfenac were observed in the majority of subjects 2 and 3 hours post dose, respectively, following bilateral topical ocular 3 times-daily dosing of nepafenac ophthalmic suspension, 0.1%. The mean steady-state C max for nepafenac and for amfenac were 0.310 ± 0.104 ng/mL and 0.422 ± 0.121 ng/mL, respectively, following ocular administration. Nepafenac at concentrations up to 300 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4).
Therefore, drug-drug interactions involving CYP-mediated metabolism of concomitantly administered drugs are unlikely. Drug-drug interactions mediated by protein binding are also unlikely.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In two double-masked, randomized clinical trials in which patients were dosed 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period, NEVANAC 0.1% demonstrated superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation. Patients treated with NEVANAC ® 0.1% were less likely to have ocular pain and measurable signs of inflammation (cells and flare) in the early postoperative period through the end of treatment than those treated with its vehicle.
For ocular pain in both studies, a significantly higher percentage of patients (approximately 80%) in the nepafenac group reported no ocular pain on the day following cataract surgery (Day 1) compared to those in the vehicle group (approximately 50%). Results from clinical studies indicated that NEVANAC 0.1% has no significant effect upon IOP; however, changes in IOP may occur following cataract surgery.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay.
Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice. Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg (approximately 90 and 380 times the plasma exposure to the parent drug, nepafenac, and the active metabolite, amfenac, respectively, at the recommended human topical ophthalmic dose).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay.
Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice. Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg (approximately 90 and 380 times the plasma exposure to the parent drug, nepafenac, and the active metabolite, amfenac, respectively, at the recommended human topical ophthalmic dose).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 82667-500-03 STERILE Nevanac ® (nepafenac ophthalmic suspension) 0.1% 3 mL HARROW® carton