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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 13
August 1, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First OTC Oral Contraceptive

On July 13, 2023, the U.S. Food and Drug Administration (FDA) approved Opill® (norgestrel) tablet, a progestin-only oral contraceptive pill, for use without a prescription. It is the first oral contraceptive to be approved for over the counter (OTC) use in the U.S. Norgestrel tablet was originally approved in 1973 as a prescription product to prevent unintended pregnancy. Recent studies have shown a high proportion of consumers understood the information provided on the Opill® Drug Facts label and the label instructions which supports the FDA’s requirements for OTC approval. The availability of an OTC option may help reduce barriers to oral contraceptive access and is expected to be more effective in preventing unintended pregnancies than other nonprescription contraceptive products currently available. Opill® should be taken daily and at the same time every day to optimize effectiveness. Opill® is not an emergency contraception and does not prevent pregnancy after unprotected sex. The most common side effects include irregular vaginal bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating. Opill® should not be used by individuals who have breast cancer or a history of breast cancer, and it should not be used together with another form of hormonal birth control. Availability is expected in the first quarter of 2024. Information about pricing is not yet known and will be determined by the manufacturer, Laboratoire HRA Pharma. 

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Drug Safety

Cipla Announces Albuterol Sulfate Voluntary Recall

On July 7, 2023, the FDA announced Cipla’s voluntary nationwide recall of six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation). Albuterol inhalers are used to treat the symptoms experienced during acute asthma exacerbations including wheezing, coughing and shortness of breath. The recalled products are packaged in a plain aluminum aerosol canister with dose counter coupled with plastic actuator and dust cap. They are being recalled due to a device defect that increases the probability of not delivering the recommended dose to treat respiratory symptoms which may be life-threatening. The recall is initiated by Cipla after a complaint of leakage through the inhaler valve for one single inhaler. However, six batches of inhalers manufactured in November 2021 using this lot of valves have been recalled as a precaution. To date, there are no adverse events reported related to this recall. The company is in the process of notifying distributors and affected customers as well as arranging the return and replacement of all recalled inhalers. All customers with a product from these six batches should stop using them and discard or return them to the company or the pharmacy that dispensed the medication. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Humira®’s Changing Biosimilars Landscape

Humira® (adalimumab) is an injectable medication used in the treatment of many autoimmune disorders. These include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis, chronic plaque psoriasis and juvenile idiopathic arthritis. Humira® is a biologic medication made from living cells and belongs to the drug class known as tumor necrosis factor (TNF) blockers. TNF causes inflammation in the body, and patients with autoimmune inflammatory diseases have elevated amounts of TNF in their body. As a TNF blocker, Humira® works by stopping TNF from attacking healthy cells and causing inflammation. AbbVie’s Humira® was initially approved by the FDA in 2003 and has been under patent as the only adalimumab product available on the market. Following the expiration of the patent earlier this year, the landscape of adalimumab biosimilar products is greatly expanding. There are currently 9 FDA-approved adalimumab biosimilars entering the U.S. market. Many of these biosimilars have been approved by the FDA for several years and have been awaiting the expiration of Humira®’s patent in order to come to market. In recent years, Humira® has been the most profitable drug in the world, reaching $20.7 billion in sales in 2021. The availability of biosimilar products should drive down the cost of this therapy through increased competition in the market. Two features that vary amongst the biosimilar products for Humira® are their concentration and the presence of citrate. High-concentration products allow a patient to inject less fluid, making the injection faster and more comfortable. Most of the newly approved products are citrate-free which results in less injection site pain and irritation for patients. An additional factor that varies between these biosimilars is their FDA-approved interchangeability status with Humira®. Interchangeability status allows for easier dispensing of these medications but does not necessarily indicate superiority as compared to products that are not officially interchangeable. At this time, only one biosimilar for Humira® has been approved as interchangeable, but others have applied to obtain this status from the FDA. Patients should be aware that multiple studies have established the safety of switching to biosimilar products without impact on clinical outcomes. The expiration of Humira®’s patent along with the approval of 9 biosimilars will have an enormous impact on the market and increase adalimumab availability for many patients. 

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FDA Approvals

New FDA Approvals

New Drug: Lantidra® (donislecel-jujn)

Injectable medication made from donor pancreatic cells approved for the treatment of adults with type 1 diabetes who are unable to reach glucose control goal due to repeated episodes of severe low blood sugar despite intensive diabetes management [06/28/2023 – CELLTRANS, INC]

New Drug: Elevidys® (delandistrogene moxeparvovec-rokl)

Intravenous infusion approved for the treatment of ambulatory pediatric patients 4 through 5 years old with Duchenne muscular dystrophy (DMD) [07/13/2023 – SAREPTA THERAPEUTICS, INC]