BROMFENAC .9 mg/mL
Bromfenac · SOLUTION/ DROPS · Fosun Pharma USA Inc.
BROMFENAC is a solution/ drops containing bromfenac at .9 mg/mL, taken ophthalmic. Manufactured by Fosun Pharma USA Inc..
Key Facts
- Brand Name
- BROMFENAC
- Generic Name
- Bromfenac
- NDC Code (Product)
72266-142- Manufacturer
- Fosun Pharma USA Inc.
- Strength
- .9 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA211029
- Marketing Start
- 07/06/2020
Recall History
Promise Pharmacy, LLC
Lack of sterility assurance.
Bausch & Lomb, Inc.
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Imprimis NJOF, LLC
Lack of Assurance of Sterility
Mayne Pharma Usa
Lack of Assurance of Sterility: Failed preservative effectiveness test
Imprimis NJOF, LLC
Subpotent Drug
Promise Pharmacy, LLC
Lack of sterility assurance.
Apotex Inc.
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Sun Pharmaceutical Industries, Inc.
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications
Promise Pharmacy, LLC
Lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac 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 extraction (1) .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery (2.1) . 2.1 Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
Contraindications
4 CONTRAINDICATIONS None.
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients. 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, co…
Frequently Asked Questions
What is BROMFENAC used for?
BROMFENAC contains Bromfenac. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is BROMFENAC a controlled substance?
BROMFENAC is not classified as a controlled substance by the DEA.
What is the generic name for BROMFENAC?
The generic name for BROMFENAC is Bromfenac. There are 9 other brand versions of Bromfenac.
What is the NDC code for BROMFENAC .9 mg/mL?
The NDC (National Drug Code) for BROMFENAC .9 mg/mL is 72266-142, listed by Fosun Pharma USA Inc..
Other BROMFENAC Dosages
Other Bromfenac Brands
See all →- Bromfenac1.035 mg/mL72485-649
- bromfenac 0.075%.76 mg/mL49708-755
- Bromfenac.7 mg/mL60219-1526
- Bromfenac Ophthalmic Solution, 0.07%.7 mg/mL60505-1006
- Prolensa.7 mg/mL24208-602
- bromfenac1.035 mg/mL46708-508
- bromfenac ophthalmic solution.7 mg/mL75907-093
- BROMFENAC SODIUM.805 mg/mL46708-583
- Bromfenac.9 mg/mL68180-436
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)