Azurity Pharmaceuticals Receives FDA Approval for Lamlique Oral Suspension
News related to:Azurity Pharmaceuticals · 4 min read
Woburn, MA, Sept. 28, 2026 /CourierPR/ -- Azurity Pharmaceuticals has received FDA approval for Lamlique™ (lamotrigine) oral suspension, a ready-to-use oral liquid formulation of lamotrigine designed to support individualized epilepsy treatment. This new formulation is approved for adjunctive therapy in patients aged 2 years and older for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures of Lennox-Gastaut syndrome. Additionally, it is approved for conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with certain other antiepileptic drugs, and for maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adult patients treated for acute mood episodes with standard therapy.
Lamlique™ builds on the established clinical experience of lamotrigine and offers a ready-to-use oral liquid formulation that can support patients whose treatment needs evolve over time, including those who may benefit from dosing flexibility or an alternative to solid oral dosage forms. Lamlique does not require compounding or refrigeration and is available in two strengths, 5 mg/mL and 25 mg/mL. The company believes that medicines should work not only in controlled settings but in the realities of everyday life, and this new formulation is an example of their commitment to improving the treatment experience for patients.
Epilepsy affects approximately 3.4 million people in the United States, including over 450,000 children.1 While lamotrigine remains an established treatment option, for some patients, dosage form and dosing considerations can be important factors in treatment. Lamlique provides a ready-to-use oral liquid formulation of lamotrigine, offering an additional administration option for appropriate patients.
Lamlique is expected to be available by the end of the year 2026. The company, which is privately held and global, has a mission to redefining medicine for the real world. With more than 70 medicines across 11 therapeutic areas, Azurity's portfolio reaches millions of people in more than 50 countries. For complete information, including the BOXED WARNING, see Important Safety Information and the Prescribing Information.
It is important to note that LAMLIQUE may cause a serious skin rash that may cause hospitalization or even death. A serious skin rash can happen at any time during treatment with LAMLIQUE, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash. The risk of getting a serious skin rash is higher if the patient takes LAMLIQUE while taking valproate, takes a higher starting dose of LAMLIQUE than prescribed, or increases the dose of LAMLIQUE faster than prescribed. The risk of serious skin reactions may be associated with a variant in genes called HLA-B*1502 in people from Asian origin (mainly of Han Chinese and Thai origin).
Other serious reactions, including serious blood problems or liver problems, may also occur. LAMLIQUE can also cause other types of allergic reactions or serious problems that may affect organs and other parts of the body, such as the liver or blood cells. Call your healthcare provider right away if you have any of these symptoms: fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, looking pale, weakness, fatigue, yellowing of your skin or the white part of your eyes, trouble walking or seeing, seizures for the first time or happening more often, pain or tenderness in the area towards the top of your stomach (enlarged liver or spleen).
LAMLIQUE may also cause abnormal heart rhythms, which may be life-threatening. This risk may be increased in people with underlying heart problems. Call your healthcare provider right away if you have a fast, slow, or pounding heartbeat, loss of consciousness (fainting), dizziness, shortness of breath, or chest pain.
Like other antiepileptic drugs, LAMLIQUE may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, suicide attempt, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry, or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), other unusual changes in behavior or mood.
Do not stop LAMLIQUE without first talking to a healthcare provider. Stopping LAMLIQUE suddenly can cause serious problems, such as having seizures that do not stop. LAMLIQUE may also cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord. Call your healthcare provider right away if you have any symptoms of headache, fever, nausea, vomiting, stiff neck, rash, unusual sensitivity to light, muscle pains, chills, confusion, or drowsiness.