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Supernus Pharmaceuticals’ Qelbree® (viloxazine extended-release capsules) has received an expanded indication to treat attention deficit hyperactivity disorder (ADHD) in adults as well as in pediatric patients six years old and up.

• The S. FDA originally approved Qelbree in 2021 to treat ADHD in patients 6-17 years of age. The drug is the first new nonstimulant ADHD treatment to receive FDA approval for adults since 2002.
• Recommended dosing is:
  • Patients 6-11 years old: 100mg once daily to start, with the option to titrate in increments of 100 g weekly to a maximum recommended dose of 400mg once daily.
  • Patients 12-17 years old: 200mg once daily, with the option to increase the dosage by 200mg after one week to the maximum recommended dose of 400mg once daily.
  • Patients 18 years old and up: 200mg once daily, with the option to titrate in increments of 200mg weekly to a maximum recommended dose of 600mg once daily.

The U.S. FDA has approved Cuvrior™ (trientine tetrahydrochloride) to treat stable Wilson’s disease in adults who are de-coppered and tolerant to penicillamine, an FDA-approved first-line treatment for the disease.

• Wilson’s disease is a rare, genetic disorder in which the body cannot properly filter out copper. The excess copper that remains is stored in various bodily tissues, including the eyes, liver, and brain. De-coppering is the process of using chelating agents to help remove copper from the body.
• Cuvrior is taken by mouth on an empty stomach twice per day. The total daily dose can range from 300mg to 3,000mg, with dosing adjusted according to clinical assessment and laboratory monitoring of copper.
• Orphalan, the manufacturer, plans to launch Cuvrior in early 2023.

The U.S. FDA has approved the first therapeutically equivalent generics for Takeda’s Velcade® (bortezomib). Although Fresenius and Dr. Reddy’s have marketed generic bortezomib for several years, the U.S. FDA does not consider their products therapeutically equivalent because of differences in formulation.

• There are now eight approved bortezomib generics considered therapeutically equivalent by the FDA. They are available in the form of single-use vials containing 3.5mg bortezomib as a lyophilized cake or powder for reconstitution.
• Recommended dosing for bortezomib is 1.3mg/m² of the patient’s body surface area, given as either a 3-5 second bolus intravenous injection or a subcutaneous The dosing schedule and treatment duration depend on the indication and other patient-specific factors.
• The following manufacturers have launched their newly approved bortezomib generics: Apotex, Aurobindo, Baxter, Fresenius Kabi, Ingenus, Sagent, and Zydus.

• Alimta (pemetrexed) – for cancer
• Banzel 100mg tablets (rufinamide) – for seizures
• Velcade (bortezomib) – for cancer

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.accessdata.fda.gov/scripts/medwatch/index.cfm
• Send a Report Via U.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.

The U.S FDA has approved Rinvoq® (upadacitinib – AbbVie) to treat active ankylosing spondylitis (AS) in adults who have an inadequate response or intolerance to one or more tumor necrosis factor blockers.

• AS is a chronic inflammatory disease that can cause bones in the spine to fuse together. Rinvoq, which first received FDA approval in 2019, is also indicated to treat rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis.
• The recommended dose to treat AS is 15mg of Rinvoq taken by mouth once daily.

AstraZeneca’s Ultomiris® (ravulizumab-cwvz) is now approved to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive.

• Myasthenia gravis is a rare neuromuscular condition that causes severe weakness and loss of muscle function. Ultomiris is the first drug in its class approved to treat gMG.
• The FDA first approved Ultomiris in The drug is also indicated to treat paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome in patients at least one month of age.
• Recommended dosing is based on the patient’s diagnosis and body. To treat gMG, Ultomiris is administered via intravenous infusion once every eight weeks.

Vivjoa™ (oteseconazole capsules – Mycovia Pharmaceuticals) has received FDA approval to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females who have a history of RVVC and are not of reproductive potential.

• RVVC is also known as chronic yeast infection and defined by the S. Centers for Disease Control as three or more symptomatic acute episodes of yeast infection within 12 months. Vivjoa is the first medication FDA approved specifically for treatment of RVVC.
• Vivjoa is taken by mouth with Recommended dosing is as follows:
  • Treatment with Vivjoa ONLY: Administer 600mg on Day 1 and 450mg on Day Beginning on Day 14, administer 150mg once every seven days for 11 weeks.
  • Treatment with Vivjoa and fluconazole: Administer fluconazole 150mg by mouth on Days 1, 4, and On Days 14 through 20, administer Vivjoa 150mg once daily. Beginning on Day 28, administer Vivjoa 150mg once every seven days for 11 weeks.
• Launch and pricing information are not available.

Bristol Myers Squibb’s Camzyos™ (mavacamten) has been approved to improve functional capacity and symptoms as a treatment for symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) in adults. Camzyos is the first drug in its class to receive FDA approval for this indication.

• Obstructive HCM occurs when a wall of muscle in the heart becomes thicker than normal and interferes with blood flow. Usually, the condition is caused by genetic mutations.
• Due to a risk of heart failure, Camzyos dosing must be individualized based on the patient’s clinical status and echocardiographic assessments of treatment response. The medication is taken once daily by mouth.
• Camzyos has launched at an annual wholesale acquisition cost (WAC) of $89,500.

Caplyta® (lumateperone) has received FDA approval for two new dosages strengths: 10.5mg capsules and 21mg capsules.

• First FDA approved in 2019, Caplyta is indicated to treat schizophrenia, as well as depressive episodes associated with bipolar I or II disorder.
• Typical recommended dosing is 42mg taken once daily, currently available in capsule form. However, patients may require dose reduction if they are also taking moderate or strong CYP3A4 inhibitors, or if they have moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment. Recommended dosing for these patient populations is:
  • 5mg once daily for patients on moderate CYP3A4 inhibitors.
  • 21mg once daily for patients on strong CYP3A4 inhibitors or with moderate or severe hepatic impairment.
• Intra-Cellular Therapies, the manufacturer, plans to launch the new dosage strengths mid-2022.

The U.S. FDA has approved Epsolay® (benzoyl peroxide, cream, 5%), from Sol-Gel Technologies, to treat inflammatory lesions of rosacea in adults.

• Epsolay uses a proprietary microencapsulation technology that slowly release benzoyl peroxide over time. It is the first benzoyl peroxide formulation FDA approved to treat rosacea.
• Under the recommended dosing, a pea-sized amount of Epsolay is applied once daily in a thin layer to each area of the face (forehead, chin, nose, and each cheek). Any unused Epsolay must be discarded 30 days after opening.
• Epsolay has launched at a wholesale acquisition cost (WAC) of $475 per 30g pump.