Prescription medicine
Bromfenac Brand names: Prolensa, Bromsite; first approved as Bromday
Bromfenac (Prolensa) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $13.25 per mL (Bromfenac sodium 0.07% eye drp) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the bromfenac FDA label on DailyMed (effective May 5, 2026, Bausch & Lomb Americas Inc.); the NDA 21664 record on Drugs@FDA; every bromfenac label on DailyMed.
Highlights of the record
FDA label of May 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Forms and strengths
- 0.7 mg/ml
- 0.75 mg/ml
- 0.76 mg/ml
- 0.805 mg/ml
- 0.9 mg/ml
- 1.035 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- March 24, 2005 Bromday, Bausch And Lomb Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first May 11, 2011; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 9 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 11, 2033 Prolensa solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $13.25 per mL Bromfenac sodium 0.07% eye drp
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2015 0 Class I among all firms' recalls; latest May 7, 2025
- FAERS reports
- 2,405 through July 30, 2026
What is bromfenac used for?
From the label: indications and usageBromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Conditions named in the indications of bromfenac's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (bromfenac ophthalmic solution), Bausch & Lomb Americas Inc., effective May 5, 2026 (SPL set 246e2110-6a2d-4e22-8e37-72d80796b9af), via openFDA; the full label on DailyMed
Is there a generic for bromfenac (Prolensa)?
The FDA approved the first generic bromfenac on May 11, 2011. 16 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bromfenac from 9 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Prolensa solution/drops, the last expiring on November 11, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2011 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bromfenac (Prolensa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.25 per mL (Bromfenac sodium 0.07% eye drp), down 10% from $14.72 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bromfenac sodium 0.07% eye drp (generic)
- Bromsite 0.075% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bromfenac sod 0.075% eye drop | Generic | $24.38 per mL | n/a | -4% |
| Bromfenac sodium 0.07% eye drp | Generic | $13.25 per mL | n/a | -10% |
| Bromfenac sodium 0.09% eye drp | Generic | $15.63 per mL | n/a | -30% |
| Bromsite 0.075% eye drops | Brand | $49.55 per mL | n/a | -0.2% |
| Prolensa 0.07% eye drops | Brand | $115.55 per mL | n/a | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bromfenac been recalled?
The FDA's Enforcement Report lists 4 recalls naming bromfenac since 2015: 0 Class I (the most serious), 4 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 7, 2025 | Class II | Alembic Pharmaceuticals Limited | Failed Impurities/Degradation Specifications |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| January 24, 2019 | Class II | Sun Pharmaceutical Industries, Inc. | Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. |
| August 17, 2015 | Class II | Bausch & Lomb, Inc. | Lack of Assurance of Sterility: Failed preservative effectiveness testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bromfenac label say about other medicines?
The bromfenac label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Benzalkonium | warnings and precautions | The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. |
Source: FDA drug label (bromfenac ophthalmic solution), Bausch & Lomb Americas Inc., effective May 5, 2026 (SPL set 246e2110-6a2d-4e22-8e37-72d80796b9af), via openFDA; the full label on DailyMed
What do FAERS reports show for bromfenac?
The FDA Adverse Event Reporting System holds 2,405 reports that list bromfenac among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 328 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bromfenac?
4 other medicines are given the same way (ophthalmic) and in the same FDA class as bromfenac or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ketorolac | Pain | 17 labelers | $1.39 per mL 0.5% eye solution | In shortage |
| Diclofenac | Pain | 5 labelers | $1.70 per mL 0.1% eye drops | A presentation being discontinued |
| Nepafenac | Pain | none listed | $121.14 per mL 0.3% eye drops | No current entry |
| Loteprednol | Pain | 8 labelers | $10.47 per mL 0.5% drp | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bromfenac
- 4 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Bromfenac side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other