Cosette Earns Its First FDA Drug Approval With EVOXAC

Cosette Pharmaceuticals has won FDA approval for an EVOXAC (cevimeline hydrochloride) oral solution for the dry mouth that comes with Sjögren’s disease — the first New Drug Application the private, Bridgewater, New Jersey specialty drugmaker has ever taken through FDA review using its own product development work, rather than buying an already-approved brand. The company announced the approval on 20 October 2026; FDA’s own approval letter for NDA 221183 is dated five days earlier, 15 October 2026.

EVOXAC’s approval in four figures

1stCosette-developed NDA the company has won, after years of acquiring brands

2FDA-approved prescription drugs exist for Sjögren’s dry mouth: EVOXAC and Salagen

26 yrssince FDA first approved the EVOXAC capsule, 11 January 2000

Dec 16, 2025date FDA received Cosette’s oral-solution application

Figures from FDA’s approval letter for NDA 221183 and FDA’s label for NDA 020989, cross-checked against Cosette’s 20 October 2026 announcement as reported by Drug Development & Delivery and Fierce Pharma.

A drugmaker built mostly by acquisition

Cosette Pharmaceuticals is a specialty pharmaceutical company based in Bridgewater, New Jersey, with roughly 350 employees, privately held by healthcare investor Avista Capital Partners; Hamilton Lane acquired a significant equity stake and joined Avista in controlling the company in July 2024. Its roughly 30-product portfolio has been built almost entirely by acquiring branded drugs that larger companies were shedding, and by filing first-generic applications once other companies’ patents and marketing exclusivities lapse — a strategy that has produced launches of first-generic versions of TAZORAC, RECTIV and CIPRO HC, among others, plus branded acquisitions including BENICAR, WELCHOL, AMBIEN, VYLEESI and, most recently, SYMPAZAN and other products bought from Assertio in April 2026.

EVOXAC itself came to Cosette this way: in January 2022, Cosette acquired U.S. rights to EVOXAC and seven other branded products from Daiichi Sankyo, as the Japanese drugmaker shed non-oncology assets. Until this approval, every Cosette product on the market had either been developed by someone else before Cosette bought it, or was a generic copy of a drug someone else had already won approval for. NDA 221183 breaks that pattern: Cosette’s own regulatory and development teams took the EVOXAC Oral Solution application through FDA review themselves.

EVOXAC’s road from 2000 to Cosette’s own lab

1. 11 January 2000

   Original EVOXAC capsule approved

   FDA approves cevimeline hydrochloride capsules, NDA 020989, for dry mouth in Sjögren’s syndrome, then marketed by Daiichi Sankyo.

2. 18 January 2022

   Cosette acquires EVOXAC

   Cosette Pharmaceuticals buys U.S. rights to EVOXAC and seven other branded products from Daiichi Sankyo.

3. 16 December 2025

   Oral-solution application filed

   Cosette’s New Drug Application for an EVOXAC oral solution, filed under the 505(b)(2) pathway, is received by FDA.

4. 15 October 2026

   FDA approves the oral solution

   FDA approves NDA 221183 — Cosette’s first New Drug Application built through its own product development, rather than acquired already-approved.

5. End of 2026

   U.S. launch expected

   Cosette says it will share more availability details closer to its planned end-of-2026 commercial launch.

What a liquid changes for a swallow-impaired patient

Cevimeline is a cholinergic agonist that stimulates muscarinic receptors in the salivary glands, increasing saliva flow in patients whose Sjögren’s disease has left their mouths chronically dry. The EVOXAC capsule has treated that symptom since 2000; the new oral solution delivers the same active ingredient in liquid form, for patients who have difficulty swallowing solid dosage forms — a meaningful subset of an autoimmune-disease population that skews older and often has its own swallowing complications. Cosette pursued the FDA’s 505(b)(2) pathway, which let the company rely in part on the existing capsule’s safety and efficacy data rather than repeat every study from scratch.

What the approval does not do, as trade coverage of the announcement has noted, is establish that the oral solution works better than the capsule it supplements — the two are approved as alternative dosage forms of the same drug, not as a clinical upgrade. Cosette has not yet disclosed the oral solution’s specific dosing strength or volume, nor a launch price; the company says only that it expects U.S. availability by the end of 2026.

Three things the liquid form changes

01

No more capsule barrier

Patients who could not reliably swallow the EVOXAC capsule now have an FDA-approved liquid alternative delivering the same cevimeline dose, addressing a documented adherence gap in managing Sjögren’s dry mouth.

02

Built without outside help

Cosette’s own regulatory and development teams, not an acquired company’s, took NDA 221183 through FDA review end to end — the first time that has been true of anything in Cosette’s portfolio.

03

Still unproven against pilocarpine

FDA’s approval rests on bridging data to the existing capsule, not a head-to-head trial against Salagen (pilocarpine) or evidence that the liquid relieves symptoms better than either existing option.

“EVOXAC oral solution marks an important milestone for Cosette — our first NDA approval, achieved through the dedication and ingenuity of our own teams. Today, we are demonstrating that we can also create value through our own product development capabilities.” Apurva Saraf, President and Chief Executive Officer, Cosette Pharmaceuticals — 20 October 2026 announcement

Only two prescription drugs treat this

Sjögren’s-disease dry mouth has a narrow prescription field: cevimeline (EVOXAC, plus generic capsule versions from Lupin, Aurobindo and, as of March 2026, Zydus) and pilocarpine (Salagen and its generics, also approved for radiation-induced dry mouth in head-and-neck cancer patients) are the only two FDA-approved prescription drugs for the indication. A published review of the evidence found a comparably stronger case for pilocarpine’s benefit, with roughly 30% of patients discontinuing it for side effects, while it judged the evidence for cevimeline’s benefit less conclusive — a caveat worth holding alongside Cosette’s own, that this approval does not show the new liquid outperforms anything. Over-the-counter artificial-saliva products such as Biotene Oral Balance Gel, SalivaSure and Oasis Moisturizing Mouth Spray offer symptomatic relief without a prescription, but are not FDA-approved as drugs.

EVOXAC Oral Solution against the field it enters

Product	Active ingredient	Form	US status
EVOXAC Oral Solution (Cosette Pharmaceuticals)	Cevimeline HCl	Oral solution (liquid)	FDA approved, Oct 2026 (NDA 221183)
EVOXAC capsules and generic cevimeline (Cosette, Lupin, Aurobindo, Zydus)	Cevimeline HCl	Capsule	FDA approved since 2000; generics since 2017
Salagen and generic pilocarpine	Pilocarpine HCl	Tablet	FDA approved; also used for radiation-induced dry mouth
OTC artificial-saliva products (Biotene, SalivaSure, Oasis)	Non-drug moisturizers and lubricants	Gel, spray, lozenge	Over-the-counter; not FDA-approved as drugs

From FDA records, company labelling and published literature; not a clinical comparison.

A market two research firms can’t agree on

Published forecasts for the xerostomia (dry-mouth) treatment market disagree sharply, mostly because research firms define the category differently — some count only prescription sialogogues like cevimeline and pilocarpine, others fold in artificial-saliva products and broader symptomatic care. IMARC Group puts the global market at $763 million in 2024, growing roughly 3% a year to just over $1 billion by 2033; Verified Market Research puts 2025 at $1.23 billion, growing roughly 6.5% a year to $1.90 billion by 2033 — nearly double IMARC’s figure for the same end year. Neither report breaks out a figure specific to cevimeline, to oral solutions, or to the capsule-intolerant patients EVOXAC Oral Solution is actually built for.

Xerostomia treatment, by two conflicting estimates

$1.0B → $1.9B

Global xerostomia (dry mouth) therapeutics market by 2033, as forecast by two research firms whose estimates differ by nearly 2x.

2024 (IMARC)$763M

2025 (VMR)$1.23B

2033 (IMARC)$1.01B

2033 (VMR)$1.90B

Sources: IMARC Group, Xerostomia Therapeutics Market report · Verified Market Research, Xerostomia (Dry Mouth) Therapeutics Market report

Regulatory News outlook

We read the published forecasts’ wide spread as itself the headline: EVOXAC Oral Solution is entering a category researchers can’t agree is worth close to $1 billion or close to $2 billion by 2033, in a disease area with only one other approved prescription option. We’d expect EVOXAC’s own addressable slice to track nearer the low end than the high end, since the oral solution competes mainly for the minority of existing cevimeline and pilocarpine patients who specifically cannot swallow a capsule or tablet, not the broader dry-mouth population most published forecasts appear to include.

How we got here: IMARC Group’s $763 million 2024 estimate and Verified Market Research’s $1.23 billion 2025 estimate, each run forward on its own publisher-stated growth rate (roughly 3% and 6.5% CAGR respectively), reach $1.01 billion and $1.90 billion by 2033; we treat EVOXAC’s own addressable population, capsule-intolerant Sjögren’s patients specifically, as a minority share of either total, with no published figure available to cite for that narrower slice.

What end-of-2026 availability still has to clear

Cosette has cleared the regulatory hurdle; what remains is commercial. The company has not announced a specific launch date beyond “end of 2026,” a list price, or the oral solution’s exact dosing strength and volume relative to the 30 mg capsule. Nor has it said how it will market a liquid alternative to a drug that has been available, and increasingly genericized, for a quarter-century — a question that matters because Cosette’s own capsule business now competes with Lupin’s, Aurobindo’s and Zydus’s generic cevimeline capsules. For a company whose growth has come mostly from buying other companies’ approved drugs, how EVOXAC Oral Solution performs commercially will be an early public data point on what its in-house development capability is actually worth.

• What changed: FDA approved NDA 221183, EVOXAC Oral Solution (cevimeline HCl), via the 505(b)(2) pathway; the approval letter is dated 15 October 2026, and Cosette announced it on 20 October 2026.
• Why it’s a first: It is Cosette Pharmaceuticals’ first New Drug Application built through its own product development, after years of growing by acquiring other companies’ already-approved brands and filing first-generic ANDAs.
• What it doesn’t prove: FDA’s approval does not establish that the oral solution works better than the EVOXAC capsule, which has been available since 2000.
• Not yet public: a specific U.S. launch date beyond “end of 2026,” a list price, and whether the oral solution’s dosing regimen differs from the capsule’s.

Frequently asked questions

What exactly did FDA approve?

FDA approved NDA 221183, EVOXAC (cevimeline hydrochloride) Oral Solution, via the 505(b)(2) pathway. The approval letter is dated 15 October 2026; Cosette Pharmaceuticals announced it on 20 October 2026. The solution is indicated for dry mouth (xerostomia) in adults with Sjögren's disease.

Is this a brand-new drug, or a new version of an old one?

It's a new dosage form of an existing active ingredient, not a new molecule. Cevimeline, sold as EVOXAC, has been FDA-approved as a capsule since 11 January 2000 (NDA 020989). The oral solution gives patients who have difficulty swallowing capsules a liquid alternative, built in part on the capsule's existing safety and efficacy data.

Why does Cosette call this its 'first' NDA approval?

Cosette Pharmaceuticals has grown mostly by acquiring other companies' already-approved branded drugs (including the EVOXAC capsule itself, bought from Daiichi Sankyo in January 2022) and by filing ANDAs for first-generic versions of other companies' products. NDA 221183 is the first New Drug Application the company has taken through FDA review using its own product development work, rather than buying a drug someone else had already gotten approved.

When will EVOXAC Oral Solution be available?

Cosette says it expects U.S. commercial availability by the end of 2026 and will share more details closer to launch. As of this approval, the company has not announced a specific launch date, a price, or whether the solution's dosing regimen will differ from the capsule's.