New Treprostinil Formulation, Yutrepia, Approved
On May 23, 2025, the US Food and Drug Administration (FDA) granted approval to Yutrepia™ (treprostinil – Liquidia) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. This is a dry powder formulation using PRINT™ technology that enhances deep-lung delivery through a “low-effort” device since it requires less inspiratory effort. PAH is estimated to affect about 45,000 Americans, and around 60,000 patients in the US have PH-ILD. A prostaglandin analog, treprostinil works by widening blood vessels in the body and has been approved in various formulations including subcutaneous (SC) and dry powder inhalation. Yutrepia is a small, palm-sized inhaler administered three to five times daily, inhaled in two breaths. The launch is dependent on the results of ongoing patent infringement litigation with United Therapeutics which manufactures Tyvaso® (treprostinil), a nebulized formulation and a dry powder inhalation. However, Liquidia expects the product to be available within the next two weeks with a cost of $24,362 for a 28-day supply, at parity with Tyvaso. Here is the prescribing information.
First Generic Tasigna Launches
On May 27, 2025, Apotex Corporation announced the FDA approval and launch of nilotinib capsules, a generic version of Novartis’ Tasigna® (nilotinib). A tyrosine kinase inhibitor (TKI), it is indicated to treat newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) leukemia and CML with accelerated phase that are resistant or intolerant to prior TKI therapy in those greater than one year of age. It is also approved in adults with both chronic and accelerated phase Ph+CML that is resistant or intolerant to prior therapy that included imatinib. According to Novartis, Tasigna’s net sales in 2024 were $1.6 billion. Apotex was granted 180 days of generic exclusivity. Prescribing information is here.
Another Stelara Biosimilar Approved
The FDA approved Bio-Thera Solution’s Starjemza® (ustekinumab-hmny), the eighth Stelara® (ustekinumab – Johnson & Johnson Innovative Medicine)biosimilar on May 22, 2025. Starjemza, which will be available in subcutaneous (SC) and intravenous (IV) formulations, is approved for the treatment of adults with Crohn’s disease (CD) and ulcerative colitis (UC), and adult and pediatric patients with plaque psoriasis and psoriatic arthritis (PsA). By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation and immune responses. Seven other Stelara biosimilars were launched earlier this year. Hikma will be responsible for commercialization in the US, although no launch date or cost information has been provided yet. Prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
Hadlima Gets Full Interchangeability Status
Samsung Bioepis and Organon announced on May 27, 2025, that the FDA has designated Hadlima™ (adalimumab-bwwd) high-and low-concentration autoinjectors and high-concentration prefilled syringes as interchangeable biosimilars to AbbVie’s Humira® (adalimumab). This means all formulations and doses of Hadlima are now interchangeable as low-concentration prefilled syringes and single dose vials were granted interchangeability in June 2024. In states that allow substitution, these strengths can now be dispensed instead of Humira without contacting the prescriber for permission to substitute. The FDA has approved several other interchangeable biosimilars to Humira, including certain formulations of Abrilada™ (adalimumab-afzb – Pfizer), Cyltezo® (adalimumab-adbm – Boehringer Ingelheim), Hyrimoz® (adalimumab-adaz – Sandoz), Yuflyma® (adalimumab-aaty – Celltrion) and Simlandi® (adalimumab-ryvk – Teva/Alvotech). Prescribing information is here.
MenQuadfi Approved for Very Young Children
On May 23, 2025, the FDA approved Sanofi’s MenQuadfi (meningococcal groups A, C, W, Y conjugate vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y to include children aged six weeks of age and older. Previously, it was approved for those aged two years and older. The US Centers for Disease Control and Prevention (CDC) currently recommends that all adolescents receive a meningococcal vaccine, followed by a booster dose at age 16 years. If individuals aged two months and older are at increased risk of the disease, the CDC recommends they should receive the vaccine as well. Updated prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.
Tryptyr Approved for Dry Eye Disease
Alcon announced FDA approval of Tryptyr® (acoltremon ophthalmic solution) 0.003% for the treatment of signs and symptoms of dry eye disease (DED) on May 28, 2025. DED impacts 38 million Americans, although only about 10% use prescription products. Working differently than other available eye drops, Tryptyr is a TRPM8 receptor agonist that stimulates corneal nerves to increase natural tear production. Clinical studies showed a statistically significant increase in natural tear production as early as day one when compared to vehicle. The recommended dose is one drop per eye, twice daily. Launch is expected in the third quarter of 2025. Here is the prescribing information.
First Hydrocortisone Oral Solution, Khindivi, Approved
On May 28, 2025, the FDA approved Eton Pharmaceutical’s Khindivi™ (hydrocortisone) oral solution as replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. This rare condition occurs when the adrenal glands do not produce sufficient cortisol and is expected to impact 5,000 Americans between the ages of five and 17. A corticosteroid, the recommended starting dose of Khindivi is eight to 10mg/m2 daily, individualized using the lowest possible dosage divided three times per day. The ready-to-use oral liquid solution is expected to be available the week of June 2, 2025. Prescribing information is here.
Recall
Metoclopramide Recall
On May 23, 2025, Teva Pharmaceuticals USA recalled one lot of metoclopramide 10mg tablets to the consumer level. The recall was initiated because a single tablet of Torsemide 20mg was found in three bottles of the affected lot. Metoclopramide stimulates movement in the upper gastrointestinal tract to treat nausea, vomiting, gastroparesis, and gastroesophageal reflux disease (GERD). Torsemide is a loop diuretic used to treat fluid retention and high blood pressure. Since patients are at increased risk for unintended side effects outside of the metoclopramide safety profile, this recall is being conducted at the consumer level. For details on the recall, see here.