FDA Approves First Clonidine Oral Solution for Hypertension

On Oct. 24, 2025, the US Food and Drug Administration (FDA) approved Javadin^™ (clonidine hydrochloride – Azurity Pharmaceuticals), an oral solution formulation of clonidine for the treatment of hypertension. Clonidine, an alpha-2 adrenergic agonist available since the 1970s, lowers blood pressure and reduces the risk of fatal and nonfatal cardiovascular events, including strokes and myocardial infarctions. Although commonly compounded, this is the first oral solution formulation of clonidine, making it available for those who struggle with swallowing tablets or capsules. Approval was supported by data demonstrating bioequivalence to existing clonidine tablets. It is expected to be available by the end of 2025. Here is the prescribing information.

New IV Antibiotic Approved for Complicated UTIs

The FDA approved Meitheal Pharmaceuticals’ Contepo^™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, in adults 18 years and older on Oct. 22, 2025. The epoxide antibacterial works by inhibiting bacterial cell wall synthesis, offering bactericidal activity against Escherichia coli and Klebsiella pneumoniae. Approval was based on overall success (clinical cure + microbiological eradication) achieved in 63.5% of Contepo-treated patients compared to 55.6% in patients treated with piperacillin/tazobactam. The recommended dose is 6 grams intravenously (IV) every eight hours over one hour, with treatment duration up to 14 days. Safety concerns include electrolyte imbalances, QT prolongation and high sodium load (1,980 mg/vial), which require monitoring and adherence to a low-sodium diet. Prescribing information is available here.

New Indication for Dermal Filler Restylane Lyft

On Nov. 5, 2025, the FDA approved Galderma’s Restylane Lyft^® with Lidocaine (hyaluronic acid injectable gel) for a new indication for augmentation of the chin region to improve the chin profile in adults over 21 years who have mild-to-moderate chin retrusion. It is already approved for midface, facial folds and dorsal hand volume loss. The Restylane line of products includes dermal fillers that have indications for various cosmetic uses in the face and hands. Updated instructions for use are available at: www.RestylaneUSA.com

FDA Expands Linzess IBS-C Indication to Pediatrics

The FDA extended the indication of Ironwood Pharmaceuticals’ Linzess^® (linaclotide) on Nov. 4, 2025, to include pediatric patients seven years and older with irritable bowel syndrome with constipation (IBS-C). Already approved for adults with this condition, this makes it the first therapy approved for IBS-C in children. IBS-C in children is a chronic condition marked by infrequent, painful bowel movements, abdominal pain and bloating, with no known cause. Linzess is a guanylate cyclase type-C (GC-C) receptor agonist that works by increasing the frequency of bowel movements. Approval was based on extrapolated adult data and a 12-week randomized, double-blind trial in pediatric patients that showed significant improvements in abdominal pain and bowel movement frequency. The recommended dose for pediatric patients seven years and older with IBS-C is 145mcg once daily, taken on an empty stomach at least 30 minutes before the first meal. Diarrhea was the most common side effect; patients with severe diarrhea should discontinue use and rehydrate. Linzess is contraindicated in children under two years due to dehydration risk and in patients with suspected gastrointestinal obstruction. The prescribing information is here.

Expanded Caplyta Indication for Major Depressive Disorder

On Nov. 5, 2025, Johnson & Johnson Innovative Medicines’ Caplyta^® (lumateperone) received an expanded indication from the FDA as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. Caplyta is an atypical antipsychotic medication that was originally approved in 2019 to treat adults with schizophrenia. In 2021, it received a new indication for treating adults with depressive episodes associated with bipolar I and bipolar II disorder – either alone or in combination with lithium or valproate. The expanded approval for MDD was based on two phase III studies that showed significant improvement in depression symptoms when Caplyta was added to a patient’s existing antidepressant regimen. Common side effects may include dizziness, dry mouth, somnolence, nausea, fatigue and diarrhea. Changes in cholesterol, blood sugar and weight were not significantly different between patients taking Caplyta and those receiving placebo. The recommended dose of Caplyta oral capsules for all indications is 42mg daily. A boxed warning on Caplyta’s labeling reminds patients and prescribers that atypical antipsychotics should not be used to treat dementia-related psychosis in elderly patients due to an increased risk of death. In addition, children, teens and young adults who take antidepressants may be at higher risk for suicidal thoughts or behaviors. Although Caplyta is not approved for pediatric use, young adults taking it should be monitored for signs of suicidal behavior. Here is the updated prescribing information.

Darzalex Faspro Approved for Smoldering Multiple Myeloma

The FDA approved Janssen’s Darzalex Faspro^® (daratumumab/hyaluronidase-fihj) injection 1,800mg/30,000units for subcutaneous (SC) use as monotherapy for adults who have high-risk smoldering multiple myeloma (SMM) on Nov. 6, 2025. The fixed-dose SC injection is administered over three to five minutes once weekly for eight weeks, every two weeks through week 24, and then every four weeks until 39 cycles, up to 36 months, or until progression to multiple myeloma or unacceptable toxicity. Approval was based on AQUILA, an open-label, randomized study comparing Darzalex Faspro to active monitoring in 390 patients. Median progression-free survival (PFS) was not reached in the treatment arm compared to 41.5 months in the control arm (p<0.0001). Forty-one percent of patients met at least two high-risk criteria: serum monoclonal protein greater than or equal to 2g/dL, serum-free light chain ratio greater than 20, and bone marrow plasma cells greater than 20%. Safety warnings include hypersensitivity, cardiac toxicity in light chain amyloidosis, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity and interference with blood compatibility testing. Here is the updated prescribing information.