Published in Products

FDA approves Lupin's BromSite generic equivalent for postop inflammation and pain

This is editorially independent content
4 min read

Lupin Limited announced that the FDA has approved its abbreviated new drug application (ANDA) for bromfenac ophthalmic solution, 0.075%, a generic equivalent to Sun Pharmaceutical Industries Limited’s BROMSITE, for the treatment of postoperative inflammation and prevention of ocular pain for patients undergoing cataract surgery.

Let’s start with Lupin.

Headquartered in Mumbai, India, with a U.S. subsidiary in Baltimore, Maryland, Lupin is a multinational generic pharmaceutical company developing and commercializing a portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).

Click here for the company’s generic product list.

Give me the rundown on this ANDA.

An “abbreviated” NDA applies to generic drug compounds that are comparable to an FDA-approved drug product. In this case—unlike a NDA—the inclusion of preclinical and clinical data isn’t required in order to establish safety and effectiveness

See here for details on the approval process.

Hold on… didn’t Lupin already receive approval for this solution?

The indication? Yes. This concentrated solution? No.

In January 2024, the FDA approved its ANDA for bromfenac ophthalmic solution 0.07% (note the different concentration), a topical generic equivalent of Bausch + Lomb’s PROLENSA (bromfenac ophthalmic solution) 0.07%, which is indicated for the treatment of postop inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Details here.

And prior to that, in August 2023, the FDA also approved Lupin’s ANDA for bromfenac ophthalmic solution 0.09% (for the same indication) as yet another generic equivalent for Bausch + Lomb’s BROMDAY (bromfenac ophthalmic solution) 0.09%. Those details here.

Gotcha. Now talk about this drug.

The generic equivalent of BROMSITE—a nonsteroidal anti-inflammatory drug (NSAID) approved by the FDA in 1997—is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

One drop of the formulation is intended to be instilled in the affected eye twice daily (BID; morning and evening), starting 1 day prior to surgery and continuing through the day of surgery 14 days post-surgery.

See here for its full prescribing information (PI).

Any warnings or precautions noted with the brand-name version?

BromSite’s PI notes five potential issues:

  • Slow or delayed healing
  • Potential for cross-sensitivity
    • For patients who have previously exhibited sensitivities to the following drugs: acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs
  • Increased bleeding time of ocular tissue
    • Due to interference with platelet aggregation
    • Potentially in ocular tissues in conjunction with ocular surgery
  • Contact lens wear
    • Solution should not be administered while wearing lenses. The preservatives in the formulation may be absorbed by soft lenses.
  • Keratitis and corneal reactions
    • May result in epithelial breakdown, corneal thinning, erosion, ulceration, or perforation

What if the drops are used beyond the 14-day period?

Per the drug’s safety information, if the product is used more than 24 hours before surgery or beyond the 14-day post-op period, this may lead to an increased risk for corneal adverse events.

So... where will this generic version be developed?

According to Lupin—and similar to its other recently approved generic formulations—the drug will be manufactured at the company facility, located in Pithampur, India.

Lastly… when will it be available?

No official word yet, so stay tuned for launch info!