Lupin Limited announced that the FDA has approved its abbreviated new drug application (ANDA) for loteprednol etabonate ophthalmic suspension 0.2%, a generic equivalent to Alrex, a reference-listed drug (RLD) from Bausch + Lomb, Inc.
Refresh me on this company, please.
Lupin—headquartered in Mumbai, India, with a U.S. subsidiary in Baltimore, Maryland—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 the company’s generic product list.
Now, I’m familiar with a NDA … but what’s an ANDA?
An “abbreviated” NDA pertains to generic drug compounds that are comparable to a drug product that has already been FDA approved. In this case—unlike a NDA—the inclusion of preclinical and clinical data isn’t required in order to establish safety and effectiveness
And the approval process for this?
An applicant is required to test the drug on a small group of patients to evaluate whether 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 medication.
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.
This process allows the FDA to approve applications to market generic versions of brand-name drugs without the need for costly clinical trials and, as a result, provide a potentially lower-cost alternative to the commercially available brand-name medication.
Gotcha. So tell me about this drug.
The generic equivalent of Alrex—a sterile, topical anti-inflammatory corticosteroid approved by the FDA in 1998—is indicated for ophthalmic use to temporarily relieve the signs and symptoms of seasonal allergic conjunctivitis (SAC).
One drop of the formulation is intended to be instilled in the affected eye(s) four times daily (QID).
See here for Alrex’s full prescribing information (PI).
How long should the drops be used?
The drug’s safety information notes that if the product is used beyond 10 days, intraocular pressure (IOP) should be monitored.
Also, an initial prescription period and renewal of the drug order that exceeds 14 days “should be made by a physician only after reexamination of the patient with the aid of magnification.”
Any warnings associated with the brand-name version?
Prolonged use of the drug has been associated with the development of glaucoma (with optic nerve damage), visual acuity (VA) defects, cataract formation, secondary ocular infections, exacerbation/prolongation of viral infections, a delay in wound healing, and an increase in bleb formations.
Additionally, “fungal infections of the cornea may develop with prolonged use of corticosteroids.”
What about ocular adverse reactions?
Per the PI, 6-week clinical studies on Alrex noted ocular adverse reactions in 5 to 10% of patients. These included:
- Abnormal vision/blurring
- Burning on instillation
- Chemosis
- Discharge
- Dry eyes
- Epiphora
- Foreign body sensation
- Itching
- Injections
- Photophobia
So .. where will this generic version be developed?
Per Lupin, 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 later this year!