FDA-approved means a medical product, drug, device or treatment has passed the U.S. Food and Drug Administration’s review for safety and effectiveness for a specific use. Think of it like a formal safety and performance seal that allows the product to be marketed for that purpose in the U.S.; for investors, approval reduces regulatory uncertainty, enables sales and reimbursement pathways, and can materially affect a company’s revenue prospects and valuation.
lennox‐gastaut syndromemedical
Lennox‑Gastaut syndrome is a severe, childhood-onset form of epilepsy marked by frequent, multiple types of seizures and slowed cognitive development; think of it as a persistent storm of brain activity that disrupts learning and daily function. It matters to investors because it creates a clear medical need for effective drugs, devices and long-term care solutions, so clinical trial results, regulatory approvals and new therapies can strongly affect the commercial value and risk profile of healthcare companies targeting this condition.
oral filmmedical
A thin, dissolvable strip placed on the tongue or inside the cheek that delivers a controlled dose of a drug or active ingredient as it breaks down, avoiding swallowing and often bypassing parts of the digestive system. Investors care because oral films can increase patient convenience and adherence, enable faster or alternative drug delivery, and affect manufacturing costs, patentability and regulatory review—key factors in a product’s commercial potential and risk.
non-steroidal anti-inflammatory drugsmedical
Non-steroidal anti-inflammatory drugs are a class of medicines that relieve pain, reduce fever, and lower inflammation by blocking the body’s chemical signals that cause swelling and discomfort. For investors, they matter because they represent a large, often prescription-driven market whose sales, safety concerns, patent status, and competition can quickly change a drugmaker’s revenue—think of them as a bestselling consumer product line whose performance drives company value.
nsaidsmedical
Nonsteroidal anti-inflammatory drugs are a class of medicines used to reduce pain, fever, and inflammation; common examples include ibuprofen and naproxen. They matter to investors because they drive large, predictable sales across over‑the‑counter and prescription markets but are closely watched for safety issues, regulatory decisions, and generic competition—like widely used household tools whose recalls or lost exclusivity can quickly change a company’s revenue outlook.
pharmacovigilancemedical
Pharmacovigilance is the process of monitoring and assessing the safety of medicines after they are on the market, ensuring that any side effects or risks are identified and managed. For investors, it matters because it helps ensure that pharmaceutical companies maintain safe products, which can influence a company’s reputation, regulatory approval, and financial stability over time.
boxed warningregulatory
A boxed warning is the strongest safety alert a drug regulator places on a medication’s official label to highlight life‑threatening or very serious risks, similar to a bold red flag attached to a product. For investors, it matters because this warning can reduce sales, increase regulatory scrutiny, raise liability and monitoring costs, and change market perception of the drug’s future revenue and risk profile.
subcutaneousmedical
Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.
-- Adds Portfolio of Branded Products with $48.9 million in 2025 Net Sales and an Established Commercial Presence --
-- SYMPAZAN® Establishes a Neurology Rare Disease Footprint within Cosette --
-- Additional Brands include INDOCIN®, SPRIX®, ZIPSOR®, CAMBIA®, and OTREXUP® --
BRIDGEWATER, N.J.--(BUSINESS WIRE)--
Cosette Pharmaceuticals, Inc., a U.S.-based, branded specialty pharmaceutical company, announced today the closing of a definitive agreement to acquire the U.S. sales and distribution rights for a portfolio of seven branded products from Assertio Holdings, Inc. (Nasdaq: ASRT). The acquisition expands Cosette’s branded portfolio and adds the U.S. rights to SYMPAZAN®, a growing, patent-protected asset, further advancing Cosette’s disciplined growth strategy.
SYMPAZAN® (clobazam) oral film is an FDA-approved medicine for the adjunctive treatment of seizures associated with Lennox‐Gastaut Syndrome (LGS), a rare and severe form of epilepsy, in patients 2 years of age or older. SYMPAZAN® is a growing product with patent protection extending until 2040. As the first and only FDA-approved oral film formulation of clobazam, SYMPAZAN® addresses an important unmet need for LGS patients and establishes a Neurology rare disease footprint within Cosette’s branded portfolio.
“This acquisition reflects Cosette’s strategic approach to expanding our branded portfolio,” said Apurva Saraf, President and CEO of Cosette Pharmaceuticals. “It adds immediate scale through branded, on-market products and includes SYMPAZAN®, a growing, patent-protected asset in an orphan indication. Just as important, it reinforces our ability to execute strategic transactions propelling our growth. We look forward to successfully integrating these important medicines into Cosette and continuing to make them available for patients and prescribers.”
In addition to SYMPAZAN®, Cosette has acquired the rights to a portfolio that includes Assertio’s branded non-steroidal anti-inflammatory drugs (NSAIDs) treating indications in inflammation, pain management, and migraine:
OTREXUP® (methotrexate), injection for subcutaneous use
The agreement includes a transition period during which Assertio and Cosette will transfer responsibilities for the manufacture, supply, and commercialization of these products, including quality assurance, pharmacovigilance, and regulatory matters.
Products:
Please see Package Insert (PI) for full prescribing information including complete safety information:
SYMPAZAN® (clobazam) oral film: See full prescribing information for important safety information, including Boxed Warning.
INDOCIN® (indomethacin) oral suspension: See full prescribing information for important safety information, including Boxed Warning.
INDOCIN® (indomethacin) suppositories: See full prescribing information for important safety information, including Boxed Warning.
SPRIX® (ketorolac tromethamine) nasal spray: See full prescribing information for important safety information, including Boxed Warning.
ZIPSOR® (diclofenac potassium) liquid-filled capsules: See full prescribing information for important safety information, including Boxed Warning.
CAMBIA® (diclofenac potassium), for oral solution: See full prescribing information for important safety information, including Boxed Warning.
OTREXUP® (methotrexate) injection for subcutaneous use: OTREXUP® was discontinued by Assertio in August 2025.
About Cosette Pharmaceuticals
Cosette Pharmaceuticals, Inc. is a U.S.-based, leading specialty pharmaceutical company providing some of the most trusted and well-known brands in medicine — acquiring, developing, and delivering products that make a difference in patients’ lives. Cosette’s strong growth has been driven by its proven ability to maximize the value of its portfolio through best‑in‑class marketing, promotion, and strategic distribution capabilities, enabling the company to scale efficiently while continuing to invest in high-quality, patient-centered therapies. Cosette has corporate headquarters in Bridgewater, New Jersey and is supported by 350+ dedicated team members across all functional areas. Cosette is backed by Avista Healthcare Partners, a healthcare focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm (Nasdaq: HLNE). For more information, please visit www.cosettepharma.com or follow Cosette on LinkedIn.
