FDA Approves Subvenite (lamotrigine) Oral Suspension for Epilepsy and Bipolar Disorder

OWP Pharmaceuticals announced the U.S. Food and Drug Administration (FDA)  approval of  Subvenite Oral Suspension, the first and only lamotrigine oral suspension in the United States. This innovative formulation will offer treatment options for patients and healthcare providers by offering a flexible, patient-friendly alternative to tablets.

Lamotrigine is widely prescribed, but until now only solid oral dosage forms have been available. Subvenite Oral Suspension is designed for patients who have difficulty swallowing tablets, those who require individualized dosing, or prefer liquid medication formulations.

“The FDA approval of Subvenite Oral Suspension — the first and only lamotrigine oral suspension — represents a significant advancement in patient care,” said Scott Boyer, Founder and President, OWP Pharmaceuticals. “We are proud to bring this much needed treatment option to patients and clinicians, with availability anticipated later in 2025.”

Key Features and Benefits of Subvenite Oral Suspension:

- First and only FDA-approved lamotrigine oral suspension in the U.S.

- Improved accessibility: Suitable for patients with swallowing challenges, those requiring individualized dosing, or those who prefer liquid medication formulations.

- Precision dosing: Liquid formulation allows for dose titration and flexibility.

- Therapeutic reliability: Developed to deliver the expected safety and efficacy profile as lamotrigine tablets (1).

Availability

Subvenite Oral Suspension has been FDA-approved and is expected to be available in the United States later in 2025 through leading distribution channels. Full prescribing information is available at www.owppharma.com.

Indications

Subvenite is indicated for (2):

Epilepsy - adjunctive therapy in patients aged 2 years and older:

• partial-onset seizures

• primary generalized tonic-clonic (PGTC) seizures

• generalized seizures of Lennox-Gastaut syndrome.

Epilepsy - monotherapy in patients aged 16 years and older:

• Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.

Bipolar disorder:

• Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

https://en.wikipedia.org/wiki/Lamotrigine

FDA Approves Subvenite (lamotrigine) Oral Suspension for Epilepsy and Bipolar Disorder

FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.

In continuation of my update on losartan

Scienture Holdings, Inc.   announced the U.S. Food and Drug Administration (FDA)  approval of SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name Arbli (losartan potassium) Oral Suspension, 10 mg/mL. Arbli is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Arbli is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.

Arbli is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. Arbli provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. Arbli has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.

Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. Arbli is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately $292 million and a prescription volume of 68 million (TRx) for losartan in the US market.

“The approval of Arbli exemplifies our deep commitment to develop high value products that address unique and underserved patient needs. A significant number of patients can benefit from a safe and efficacious ready-to-use oral liquid formulation of losartan. We are excited with the approval of our first brand product which is part of our upcoming pipeline of novel specialty products,” remarked Shankar Hariharan, CEO of Scienture, LLC.

“We are pleased to bring to market, Arbli, a transformative therapy option containing losartan, one of the most widely prescribed molecules in its class, to patients, caregivers and healthcare professionals (HCPs). We expect to commercially launch and make Arbli available to patients in the U.S. in Q3 2025,” said Narasimhan Mani, President of Scienture, LLC.

“This announcement is extremely exciting and is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders,” said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.

REF ;https://en.wikipedia.org/wiki/Losartan

FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response. In 2023, there were over 46,000 transplants in the US and these patients need to take medication every day to fight against rejection. Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.

“We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate,” said Richard Blackburn, CEO of Azurity Pharmaceuticals. “Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Myhibbin’s ready-to-use formulation provides patients, pharmacists, and caregivers an alternative to other mycophenolate dosage forms.”

REF : https://en.wikipedia.org/wiki/Mycophenolic_acid

FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection