Caplin Steriles Limited announced that the FDA has approved its abbreviated new drug application (ANDA) for ketorolac tromethamine ophthalmic solution 0.5%, a generic equivalent to ACULAR ophthalmic solution 0.4% (Allergan Inc., an AbbVie company).
Refresh me on this company, please.
A subsidiary of India-based Caplin Point Laboratories Limited, Caplin is a sterile product manufacturing company focused on the research and development (R&D) of specifically-targeted injectables and ophthalmics.
Its U.S. presence—Caplin Steriles USA Inc, currently based in Hamilton, New Jersey—operates as a sales and marketing arm of the subsidiary company.
See here for a look at the US-based company’s product list, which include injectables in vials, pre-mixed bags, prefilled syringes, long-acting suspension/emulsion injectables, and ophthalmic products in three-piece dropper bottles.
Their market focus: U.S., Europe, Latin America (Brazil)
Now an ANDA.
Not to be confused with a new drug application (NDA), an “abbreviated” NDA refers to generic drug compounds that are comparable to an already FDA-approved drug product.
The distinct difference: Unlike an NDA, preclinical and clinical data isn’t required in order to establish safety and efficacy of a drug compound.
What’s the approval process like?
The drug must be tested on a small group of patients to evaluate whether it is “bioequivalent.” Translation: ensuring it can reach the target tissue where it is intended to work at the same time and in the same amount (concentration level) as the brand-name medication.
Go on…
To be granted approval, the generic drug would need to deliver “the same amount of active ingredients in a patient’s bloodstream in the same amount of time” as the already-approved drug.
The result: 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.
Alrighty. Now talk about this generic.
The drug is a generic equivalent to ACULAR, a nonsteroidal anti-inflammatory drug (NSAID) originally approved by the FDA in 1991 and indicated for:
- Relieving ocular itching caused by seasonal allergies (allergic conjunctivitis)
- Treating inflammation following corneal refractive surgery.
And its dosage?
One drop of the formulation is intended to be instilled in the operated eye four times daily (QID) as needed for pain and burning/stinging for up to four days following surgery.
See here for ACULAR’s full prescribing information (PI).
Any warnings associated with the brand-name version?
Notable warnings and precautions include:
- Delayed healing due to known association of topical NSAIDs causing an increase healing problems
- Cross-sensitivity or hypersensitivity to patients who have previously exhibited sensitivities to acetylsalicylic acid (Aspirin [ASA]), phenylacetic acid derivatives, and other NSAIDs.
- Increase bleeding time due to interferences with thrombocyte aggregation
- Corneal adverse effects such as keratitis. Patients with the following history may also be at an increased risk for corneal adverse events:
- Complicated ocular surgeries
- Corneal denervation
- Corneal epithelial defects
- Diabetes mellitus
- Ocular surface diseases (dry eye)
- Rheumatoid arthritis (RA)
- Repeat ocular surgeries with a short period of time
What happens if the drops are used beyond the four-day period?
Per the PI, dosing ACULAR more than one day prior to surgery or using it beyond 14 days post-surgery “may increase patient risk for the occurrence and severity of corneal adverse events.”
Gotcha. So what kind of packaging is the bottle available in?
The generic formulation is reportedly available in the following bottle sizes:
- 5 mL size bottle filled with 3 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL)
- 10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL)
- 10 mL size bottle filled with 10 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL)
Lastly… when will it be available?
No official word yet, so stay tuned for launch info later this year!