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The FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent vaccines to authorize their use as a single booster dose in younger age groups.

Both vaccines target the Omicron BA.4 and BA.5 subvariants.

• The Moderna COVID-19 bivalent vaccine is authorized for administration as a single booster dose at least 2 months following completion of primary or booster vaccination in children 6 years of age and older.
• The Pfizer-BioNTech COVID-19 bivalent vaccine is authorized for administration as a single booster dose at least 2 months following completion of primary or booster vaccination in children 5 years of age and older.

The FDA has approved chloroprocaine hydrochloride ophthalmic gel 3% (Iheezo; Harrow) for use as an ocular surface anesthesia. Iheezo is a sterile, single-use ophthalmic gel preparation administered by physicians. The treatment contains no preservatives and is safe and effective for ocular surface anesthesia, according to a Harrow press release.

• Iheezo is the first ophthalmic formulation of chloroprocaine hydrochloride, an anesthetic previously approved in injectable formulations under the brand names Nesacaine/Nesacaine- MPF for local anesthesia and Clorotekal for spinal anesthesia.
• This surface anesthesia is contraindicated in patients who have a history of hypersensitivity to any component of the medication. The drug should not be injected or administered intraoculary.
• Iheezo is physician-administered topically to the ocular surface prior to the planned surgical procedure. It is rapidly acting (about 1 to 5 minutes) and the anesthetic effect lasts around 20 minutes.
• The most common adverse reaction is mydriasis.
• Given the early FDA approval date, the commercial launch date for Iheezo will be slightly ahead of the original planned launch of May 2023.

Artivion, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has stopped the PROACT Xa clinical trial, a prospective, randomized, trial designed to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban rather than on warfarin. The decision was based on the recommendation of the independent Data and Safety Monitoring Board (DSMB) of the trial due to lack of evidence supporting non-inferiority of apixaban to warfarin for valve thrombosis and thromboembolism.

• The PROACT Xa trial was designed to determine whether apixaban would yield equivalent safety to the standard anticoagulant, warfarin.
• The trial began enrolling in April 2020. The DSMB found that blood clots, resulting in stroke, occurred more frequently in patients receiving apixaban and that continuing the trial was unlikely to achieve the primary endpoint while possibly exposing patients to increased risk.

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to

the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online: https://www.accessdatfda.gov/scripts/medwatch/index.cfm
• Send a Report Via S. Mail or Fax:

Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) announced FDA approval of OMLONTI^® (omidenepag isopropyl ophthalmic solution) 0.002% eye drops.

• Omlonti is used for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.
• Omlonti is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) and the recommended dosage is one drop in the affected eye(s) once daily in the evening.
• The risks identified with instillation of Omlonti include macular edema, including CME, in patients with aphakia, pseudophakia, or other risk factors for macular edema; ocular inflammation; the possibility of increased eye pigmentation; and eyelash changes.
• The product was released in five countries and regions beginning in February 2021.

The Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

• Tumor types with responses included pancreatic adenocarcinoma, colorectal, salivary, unknown primary, breast, soft tissue sarcoma, bronchial carcinoid, ovarian, small intestine, and cholangiocarcinoma.
• The most common adverse reactions (≥25%) in patients were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
• The recommended selpercatinib dose is based on body weight.

Guerbet, a global medical imaging company, announced FDA approval of Elucirem (Gadopiclenol), a new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI). The FDA is the first health authority to have approved Elucirem.

• Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent with high relaxivity indicated for use in adults and children aged 2 years and older, for contrast-enhanced magnetic resonance imaging (MRI).
• The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
• Elucirem will be marketed by Guerbet in the United States in bottle and pre-filled syringe form.

Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Pedmark (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.

• Pedmark is the first and only FDA-approved therapy Indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors, an area of previously significant unmet medical need.
• The safety and efficacy of Pedmark have not been established when administered following cisplatin infusions longer than 6 Pedmark may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
• For more information about product availability and patient support, please contact the Fennec HEARS™ program at 1-833-7Pedmark (1-833-773-3627) or visit fennecpharma.com.

Skysona® (elivaldogene autotemcel) is the first FDA approved therapy to slow the progression of neurologic dysfunction with early, active Cerebral Adrenoleukodystrophy (CALD) in boys 4- 17 years of age. Skysona, manufactured by bluebird bio, Inc., is a one-time gene therapy used to treat the underlying cause of CALD.

• It is anticipated that Skysona will be available by the end of 2022 and is a single-dose treatment.
• bluebird bio, has set the wholesale acquisition cost of Skysona in the U.S. at $3.0M per single- dose treatment.

Aponvie® (aprepitant) manufactured by Heron Therapeutics, Inc., a commercial- stage biotechnology company, has been approved for the prevention of postoperative nausea and vomiting (PONV) in adults.

• PONV is commonly experienced after surgery and may result in increased hospital stays, prolonged recovery time, and decreased patient satisfaction.
• Administered via a single 30-second IV injection, Aponvie is the first and only IV formulation of aprepitant for PONV prevention.
• Aponvie should not be used:
  • If you are allergic to aprepitant or any of the ingredients in Aponvie
  • If you are taking pimozide
• The launch date and pricing for Aponvie are pending.

Terlivaz® (terlipressin) has been approved for IV injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.

• HRS involving rapid reduction in kidney function is an acute, life-threatening condition that occurs in people with advanced liver disease.
• Terlivaz is contraindicated:
  • In patients experiencing hypoxia or worsening respiratory symptoms.
  • In patients with ongoing coronary, peripheral, or mesenteric ischemia.
• Terlivaz is expected to be available in the S. in the coming weeks.