Monthly Archives: March 2022

Xelstrym™ (dextroamphetamine – Noven Pharmaceuticals) is now the first FDA- approved dextroamphetamine transdermal patch for attention deficit hyperactivity disorder (ADHD). It is indicated to treat ADHD in patients who are at least six years of age.

• The active pharmaceutical ingredient of Xelstrym, dextroamphetamine, has held FDA approval since 2001 to treat ADHD. It is considered a Class II Controlled Substance.
• Recommended dosing is as follows:
  • Pediatric patients (6-17 years old): Recommended starting dose of 4.5mg/9 hours, titrated in weekly implements of 4.5mg based on tolerability and clinical effect, up to a maximum recommended dose of 18mg/9 hours.
  • Adults (18 years and up): Recommended starting dose of 9mg/9 hours, with possible dosage adjustment up to a maximum recommended dose of 18mg/9 hours based on tolerability and clinical effect.
• Per the prescribing information, Xelstrym patches should be applied two hours before an effect is needed and removed within nine hours of application. The product will be available in four dosage strengths: 5mg/9 hours, 9mg/9 hours, 13.5mg/9 hours, and 18mg/9 hours. It cannot be substituted for other amphetamine products on a milligram per milligram basis because of differences in amphetamine base compositions and pharmacokinetic profiles.
• Launch and pricing information are not yet available.

Nobelpharma’s Hyftor® (sirolimus) topical gel has been granted FDA approval to treat angiofibroma associated with tuberous sclerosis in patients who are at least three years old.

• Tuberous sclerosis is a rare genetic disorder that causes noncancerous but potentially life-threatening tumors. Most individuals diagnosed with the condition develop facial angiofibromas, which are growths made up of blood vessels and fibrous tissue.
• Hyftor is a topical formulation of sirolimus, a drug that first received FDA approval in 1999. Under the recommended dosing, it should be applied to the affected skin of the face twice daily. The maximum recommended daily dose is:
  • 600mg (2cm) for patients 6–11 years of age.
  • 800mg (2.5cm) for patients 12 years of age and older.
• Launch and pricing information are not yet available.

March 21, 2022 – The U.S. FDA has approved Keytruda® (pembrolizumab) to treat advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. An FDA-approved test must confirm MSI-H or dMMR status.

• This is Keytruda’s fourth indication to treat gynecological Originally FDA approved in 2014, Keytruda holds more than 30 indications to treat various types of cancer.
• Recommended dosing for endometrial carcinoma is 200mg administered by intravenous infusion once every three weeks or 400mg once every six weeks, for up to 24 months or until disease progression or unacceptable toxicity occur.

Perrigo has received FDA approval to market Nasonex® 24Hr Allergy (mometasone furoate monohydrate) 50mcg nasal spray as an over the counter (OTC) drug. Previously, mometasone nasal spray required a prescription.

• Nasonex was formerly a brand name prescription drug made by Merck Pharmaceuticals. After Merck discontinued the product, mometasone nasal spray was only available from generic manufacturers. The prescription version of the drug is indicated to treat allergies and nasal
• Perrigo’s OTC product is indicated for the temporary relief of symptoms of hay fever or other upper respiratory allergies. The company plans to launch Nasonex 24Hr Allergy later this year.

Ztalmy® (ganaxolone) oral suspension, made by Marinus Pharmaceuticals, has become the first FDA-approved treatment for cyclin-dependent kinase-like 5 deficiency disorder (CDD). It is indicated to treat seizures associated with CDD in patients who are at least two years old.

• CDD is a rare, difficult-to-treat form of epilepsy caused by a genetic mutation. Although other anti-seizure drugs are used off-label for CDD, there has been little clinical evidence to guide treatment decisions.
• Recommended dosing for Ztalmy is based on the patient’s weight:
  • 28kg (62 pounds) or less: Starting dosage is 6mg/kg of the patient’s weight three times daily (18mg/kg/day), which can be titrated up to a maximum dosage of 21mg/kg three times daily (63mg/kg/daily).

• Greater than 28kg: Starting dosage is 150mg three times daily (450mg daily), which can be titrated up to a maximum dosage of 600mg three times daily (1,800mg daily).

• Ztalmy is expected to launch in July 2022 with a wholesale acquisition cost of $2,425 per 110mL bottle containing 50mg of ganaxolone per milliliter. It is currently awaiting controlled substance scheduling by the U.S. Drug Enforcement Administration (DEA).

Bristol Myers Squibb’s (BMS) Opdualag™ (nivolumab and relatlimab-rmbw) has received FDA approval to treat unresectable or metastatic melanoma in patients who are at least 12 years old.

• Opdualag combines nivolumab, the active pharmaceutical ingredient (API) in BMS’s Opdivo®, with a first-in-class LAG-3-blocking antibody, Both APIs help to increase the body’s immune activity to fight cancer cells.
• In adults and pediatric patients who are at least 12 years old and weigh at least 40kg (88 pounds), the recommended dosing is 480mg nivolumab and 160mg relatlimab administered by intravenous infusion once every four weeks until disease progression or unacceptable toxicity occur. The recommended dosing has not been established for pediatric patients at least 12 years of age who weigh less than 40kg.
• Although launch plans are not yet available, Opdualag is anticipated to have a wholesale acquisition cost (WAC) of $27,389 per infusion.

March 16, 2022 – Rinvoq® (upadacitinib), made by AbbVie, has a new indication to treatment moderately to severely active ulcerative colitis in adults who have had an inadequate response or intolerance to at least one tumor necrosis factor blocker.

• Recommended dosing under the new indication is 45mg once daily for eight weeks, followed by maintenance dosing of 15mg once daily. For patients who have refractory, severe, or extensive disease, a dose of 30mg once daily can be considered. Rinvoq should be used at the lowest effective dose to maintain response and should be discontinued if an adequate therapeutic response is not achieved at the 30mg dosage.
• First FDA approved in 2019, Rinvoq is also indicated to treat rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

The U.S. FDA has approved Mylan’s Breyna®, a generic for AstraZeneca’s Symbicort® (budesonide/formoterol fumarate dihydrate) inhalation aerosol. Brand name Symbicort first received FDA approval in 2006, and an authorized generic from Prasco launched in 2020.

• The first AB-rated generic for Symbicort, Breyna is indicated to provide:
  • Asthma treatment for patients at least six years of
  • Maintenance treatment for airflow obstruction and to reduce exacerbations for patients who have chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
• Recommended dosing is as follows:
  • Asthma (patients at least 12 years old): Two inhalations twice daily of either 80mcg budesonide/4.5mcg formoterol or 160mcg budesonide/4.5mcg formoterol. The starting dosage strength is based on asthma severity.
  • Asthma (patients six to less than 12 years old): Two 80mcg/4.5mcg inhalations twice
  • COPD: Two 160mcg/4.5mcg inhalations twice
• Mylan hopes to launch Breyna in 2022, depending on the outcome of patent litigation. Pricing information is not yet available.

Adlarity® (donepezil transdermal system) is FDA approved to treat mild, moderate, and severe Alzheimer-type dementia. It is the first once-weekly donepezil patch approved for this use in the United States.

• Made by Corium, Adlarity comes in 5mg/day and 10mg/day
• Recommended initial dosing is one 5mg/day patch applied per week. If needed, the dose can be increased after 4-6 weeks to one 10mg/day patch each week.
• Adlarity is expected to launch in the fall of Pricing is not yet available.

Lynparza® (olaparib – AstraZeneca and Merck) is now FDA approved as an adjuvant treatment for patients diagnosed with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer who have already received chemotherapy either before or after surgery.

• Lynparza is the first drug in its class (PARP inhibitors) to receive FDA approval for treatment of early breast cancer.
• The FDA first approved Lynparza in 2014 to treat ovarian The drug has since gained indications to treat pancreatic cancer, prostate cancer, and metastatic breast cancer.
• Recommended dosing for early breast cancer is 300mg taken twice daily for a total of one year, or until disease recurrence or unacceptable toxicity occur.