Lupin Limited announced the FDA has approved its abbreviated new drug application (ANDA) for bromfenac ophthalmic solution 0.09%, to market a generic equivalent of Bausch + Lomb Inc’s Bromday ophthalmic solution.
What exactly is an ANDA?
An abbreviated new drug application (ANDA) is an application for a U.S. generic drug to be approved for an existing licensed medication or approved drug.
If approved, an applicant is permitted to manufacture and market that generic drug product as a safe, effective, and lower cost alternative to the brand-name drug it is based on.
How does this differ from an NDA?
Unlike a new drug application (NDA), an “abbreviated” NDA is typically not required to include preclinical and clinical data in order to establish safety and effectiveness.
Further, this process enables the FDA to approve applications to market generic versions of brand-name drugs without the need for costly clinical trials (to establish safety and efficacy) that have already been conducted.
So how does it get approved?
Per the FDA, an applicant must test the drug on a small group of patients and demonstrate that the drug is “bioequivalent,” meaning it can reach the part of the body where it is intended to work at the same time and in the same amount (concentration level) as the brand-name drug.
To be approved, the generic drug must deliver “the same amount of active ingredients in a patient’s bloodstream in the same amount of time” as the already-approved drug.
Gotcha. Now tell me about this company.
Headquartered in Mumbai, India, with a U.S. subsidiary in Baltimore, Maryland, Lupin Limited is a multinational generic pharmaceutical company developing and commercializing a portfolio of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs).
Its areas of focus include:
- Pediatrics
- Cardiovascular
- Anti-infective
- Diabetes
- Asthma
- Anti-tuberculosis
Click here for a product list.
And this drug?
As a topical, nonsteroidal anti-inflammatory drug (NSAID), bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain following cataract surgery.
What's the dosage?
One drop of the solution is intended to be applied to the affected eye(s) once daily starting one day prior to surgery, the day of surgery, and through the first 14 days following surgery.
To note, the solution is a reference-listed drug (RLD).
Explain RLD.
A RLD is an FDA-approved drug that can be referred to by a generic drug manufacturer (such as Lupin) while filing an ANDA.
In the case of bromfenac ophthalmic solution, the following companies have previously received approval to commercially market it in varying concentrations:
- Bromday (bromfenac ophthalmic solution 0.09%; Bausch + Lomb)*
- Prolensa (bromfenac ophthalmic solution 0.07%; Bausch + Lomb)
- Xibrom (bromfenac ophthalmic solution 0.09%; ISTA Pharmaceuticals)†
- BromSite (bromfenac ophthalmic solution 0.075%; Sun Pharmaceutical Industries, Inc.)
*Bromday was discontinued between 2012 and 2013 upon the launch of Prolensa.
†Xibrom was discontinued in 2011. Further, ISTA Pharmaceuticals was acquired by Bausch + Lomb in 2012.
Additionally, there are various companies who might compound and combine bromfenac with other molecules such as antibiotics and steroids.
See here for the complete list.
So where is this generic being developed?
According to Lupin, the solution will be manufactured at the company’s facility in Pithampur, India.
Lastly… what’s next?
With this ANDA approval, Lupin’s bromfenac ophthalmic solution 0.09% will now be listed in the FDA’s Orange Book (which includes all drugs the FDA has found to be safe, effective, and low-cost alternatives to brand-name drugs). This information is also searchable via the National Library of Medicine’s DailyMed.