India-based FDC Limited has reportedly received FDA approval for several concentrations of pilocarpine hydrochloride (HCl) ophthalmic solution.
Let’s start with FDC Limited.
Also known as FDC India—and originally founded in 1936 as Fairdeal Corporation—the pharmaceutical and healthcare company specializes in developing, manufacturing, and marketing formulations and active pharmaceutical ingredients (APIs) distributed worldwide.
Its product portfolio includes prescription-based and over-the-counter (OTC) drugs.
- And the therapeutic areas covered: ophthalmology, anti-infective, gastroenterology, dermatology, cardiovascular, and nutraceuticals.
Now to this approval.
Let’s first take note: The FDA approved an abbreviated new drug application (ANDA) for pilocarpine—not a standard NDA.
What this is: An ANDA refers to generic drug compounds that are comparable to an already FDA-approved drug product.
- How this compares to an NDA: Unlike an NDA, preclinical and clinical data aren’t required for an ANDA to establish the safety and efficacy of a drug compound.
See here for details on the approval process, which essentially must prove that the generic drug is "bioequivalent” to its name-brand counterpart.
- And check out other recent ANDA approvals.
And in this case?
The FDA approved pilocarpine HCl in three concentrations: 1%, 2%, and 4% (each in 15 mL packages).
Importantly: No official press release has been issued regarding this announcement; the news was disclosed to BSE Limited and the National Stock Exchange (NSE) of India on Oct. 4.
Further, no details were released as to the solution’s intended indications or dosing (including prescribing information).
Got it. So what do we know about this ophthalmic solution?
We can cover the science behind it—and the general indications/dosings associated with its common indications (glaucoma and ocular hypertension [OHT]).
Alrighty then. Tell me about it.
Pilocarpine HCl is a cholinergic agonist—a pupil-constricting medication—prepared as a sterile topical ophthalmic solution.
Its mechanism of action involves directly stimulating muscarinic receptors within the eye to cause ciliary muscle contraction and increased outflow of aqueous humor via the trabecular meshwork.
- In turn, this leads to reduced intraocular pressure (IOP) in the eye.
With that in mind, what conditions does it treat?
Pilocarpine HCl is typically indicated for:
- Reduction of elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT)
- Management of acute angle-closure glaucoma (ACC)
- Prevention of postoperative elevated IOP associated with laser surgery
And its recommended dosings?
Administered topically, the recommended dosings depend on the indication (see here for guidance on use with other topical ophthalmic medications and for pediatric patients).
- For reduced IOP among OAG or OHT patients: One drop (of any concentration) should be applied in the eye(s) up to four times daily (QID)
- For ACC management: For initial management, one drop (1% or 2%) may be applied to the eye(s) up to three times (TID) over a 30-minute period
- For post-op elevated IOP: One drop (or two drops, administered 5 minutes apart) applied to the eye(s) 15 to 60 minutes prior to surgery
Any potential adverse reactions associated with its use?
A few have been called out following clinical research among glaucoma and OHT patients (who were dosed with varying concentrations of the formulation).
The most frequently reported include: Headache or browache, accommodative change, blurred vision, eye irritation, visual impairment (such as dim, dark, or “jumping vision”), and eye pain.
- To note: These were adverse reactions that occurred in ≥5% of patients.
Duly noted. So … where will this be available for purchase?
Good question.
At the moment, that’s currently to be determined. Check back at FDC Limited’s product site for updates on this.
Editor's note: This story was updated and republished on Oct. 14, 2025.