Monthly Archives: May 2022

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.