NDC 62332-508 Bromfenac Ophthalmic Solution 0.09%

Bromfenac Ophthalmic Solution 0.09%

NDC Product Code 62332-508

NDC Code: 62332-508

Proprietary Name: Bromfenac Ophthalmic Solution 0.09% What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Bromfenac Ophthalmic Solution 0.09% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 62332 - Alembic Pharmaceuticals Inc.
    • 62332-508 - Bromfenac Ophthalmic Solution 0.09%

NDC 62332-508-17

Package Description: 1 BOTTLE in 1 CARTON > 1.7 mL in 1 BOTTLE

NDC Product Information

Bromfenac Ophthalmic Solution 0.09% with NDC 62332-508 is a a human prescription drug product labeled by Alembic Pharmaceuticals Inc.. The generic name of Bromfenac Ophthalmic Solution 0.09% is bromfenac ophthalmic solution 0.09%. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Alembic Pharmaceuticals Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Bromfenac Ophthalmic Solution 0.09% Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BROMFENAC SODIUM 1.035 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM SULFITE (UNII: VTK01UQK3G)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Compounds - [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alembic Pharmaceuticals Inc.
Labeler Code: 62332
FDA Application Number: ANDA210560 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-21-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bromfenac Ophthalmic Solution 0.09% Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications & 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.

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(s) 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.

3 Dosage Forms & Strengths

Topical ophthalmic solution: bromfenac 0.09%.

4 Contraindications

None.

5.1 Sulfite Allergic Reactions

Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

5.2 Slow Or Delayed Healing

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) 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.

5.3 Potential For Cross-Sensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.4 Increased Bleeding Time

With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

5.5 Keratitis And Corneal Reactions

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 and should be closely monitored for corneal health. Post-marketing 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. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

5.6 Contact Lens Wear

Bromfenac should not be administered while wearing contact lenses.

6.1 Clinical Trail 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, corneal thinning, and epithelial breakdown. [see Warnings and Precautions (5)]

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nonteratogenic Effects:Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.

8.3 Nursing Mothers

Caution should be exercised when bromfenac is administered to a nursing woman.

8.4 Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 have not been established.

8.5 Geriatric Use

There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.

11 Description

Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C15H11BrNNaO3• 3/2 H2O. The structural structure for bromfenac sodium is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.16. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg.Each mL of bromfenac ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035%Preservative: benzalkonium chloride (0.05 mg/mL)Inactives: boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). sodium hydroxide may be used to adjust pH and water for injection USP.

12.1 Mechanism Of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

12.3 Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.09% in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (1300 and 450 times RHOD, respectively).

14.1 Ocular Inflammation And Pain Following Cataract Surgery

Clinical efficacy was evaluated in three randomized, double-masked, placebo controlled trials in which subjects requiring cataract surgery were assigned to Bromfenac ophthalmic solution or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.In 2 of the 3 studies, bromfenac ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46-47% vs. 25-29%) and also had a statistically significant higher incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs. 51-71%).

16 How Supplied/Storage And Handling

Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE screw neck bottle with a LDPE white nozzle and HDPE gray cap as follows: 1.7 mL in 5 mL container - NDC 62332-508-17STORAGE: Store at 15º to 25ºC (59º to 77ºF)

17.1 Slowed Or Delayed Healing

Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs.

17.2 Sterility Of Dropper Tip

Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.

17.3 Concomitant Use Of Contact Lenses

Contact lenses should not be worn during the use of this product.

17.4 Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.Rx OnlyManufactured for:Alembic Pharmaceutical, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Made in India.Manufactured by:Gland Pharma Limited Survey No. 143-148, 150 & 151, Near Gandimaisamma Cross Roads, D.P. Pally, Quthubullapur Mandal, Ranga Reddy District, Dundigal (Post), Hyderabad-500 043, Telangana, India (IND)Issued: 03/2017

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