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Xarelto® (rivaroxaban) has been approved for two new pediatric indications. The FDA also approved a new oral suspension dosage form of the drug.

• Xarelto is now indicated for use in pediatric patients under 18 years of age to treat venous thromboembolism (VTE) and reduce the risk of recurrent VTE following at least five days of initial parenteral (injected or intravenous) anticoagulant treatment.
• It is also indicated to prevent blood clots and blood-clot related events in children at least two years of age who have congenital heart disease and have undergone the Fontan procedure (a type of open-heart surgery).
• Recommended dosing for pediatric patients is based on the patient’s weight and diagnosis. The medication should be taken with food to increase absorption into the body.
• Xarelto first received FDA approval in 2011 as an oral tablet and holds nine additional indications to treat or prevent problems caused by blood clots such as pulmonary embolism, deep vein thrombosis, and strokes.

Iyuzeh Ophthalmic Solution Approved for Open-Angle Glaucoma and Ocular Hypertension

Thea Pharma, Inc. (“Thea”), the U.S. subsidiary of Europe’s leading independent pharmaceutical company, Laboratoires Théa, has announced the U.S. Food and Drug Administration (FDA) approval for the New Drug Application (NDA) of Iyuzeh™ (latanoprost ophthalmic solution) 0.005% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Iyuzeh is the first and only clinically proven formulation of latanoprost available in the United States that is preservative-free. Iyuzeh is formulated without any of the preservatives commonly used in topical ocular preparations, including benzalkonium chloride (BAK). Iyuzeh has demonstrated consistent IOPlowering effects and proven tolerability across multiple trials in the U.S. and Europe.

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ANI Pharmaceuticals has announced U.S. FDA approval of the company’s Purified Cortrophin™ Gel (repository corticotropin injection). The product is indicated to treat certain rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, proteinuria, and acute exacerbations of multiple sclerosis.

• Recommended dosing is based on factors that include the indication, severity of disease, and general medical condition of the patient. Purified Cortrophin Gel is administered either subcutaneously or intramuscularly and can be self-administered or administered by a caregiver.
• ANI Pharmaceuticals plans to launch the drug during the first quarter of 2022. Pricing is not yet available.

The U.S. FDA has approved a new indication for Ocular Therapeutix’s Dextenza® (dexamethasone ophthalmic insert) to treat ocular itching associated with allergic conjunctivitis.

• Dextenza is a small insert placed by a healthcare professional inside a natural opening in the lower eyelid through which tears drain. It contains a 30-day supply of dexamethasone (a corticosteroid and current standard of care) and releases 0.4mg of the drug per
• First FDA approved in 2018, Dextenza is also indicated to treat ocular inflammation and pain following ophthalmic surgery.

Jakafi® (ruxolitinib) is now FDA approved to treat chronic graft-versus-host disease (cGVHD) in patients who are at least 12 years old and have failed treatment with one or two lines of systemic therapy.

• Graft-versus host disease occurs when stem cells from donated bone marrow attack healthy cells in the recipient’s body. It can be acute (occurring within 100 days of the transplant) or chronic (occurring 100 days or more after the transplant).
• In addition to treating cGVHD, Jakafi is also indicated to treat acute graft-versus-host disease, polycythemia vera (a type of blood cancer), and intermediate or high-risk myelofibrosis (a type of bone marrow cancer).
• The recommended starting dose for the new indication is 10mg taken by mouth twice daily. The daily dose may need to be reduced based on patient response and other clinical
• Jakafi, which is made by Incyte, first received FDA approval in

Opzelura™ (ruxolitinib) cream, manufactured by Incyte, has won U.S. FDA approval to treat mild to moderate atopic dermatitis in non-immunocompromised patients ages 12 years and up.

• Indicated for short-term and non-continuous chronic treatment, Opzelura is approved only for use in patients whose disease is not adequately controlled with other topical prescription therapies or for whom those therapies are inadvisable. It is the first topical formulation in a drug class known as JAK inhibitors to receive FDA approval.
• Recommended dosing is a thin layer applied to affected areas of the skin twice daily. The cream should not be used on more than 20% of the body surface and no more than 60g should be used per week.
• Opzelura has a wholesale acquisition cost (WAC) of $1,950 per 60g tube.

Dalvance® (dalbavancin – AbbVie) has received expanded U.S. FDA approval to treat acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms in patients of all ages. It was previously approved for use only in patients at least 18 years of age.

Acute infections of the skin and skin structures caused by bacteria affect an estimated 14 million people in the United States each year and are responsible for over 3 million emergency room visits. On average, hospitalization for ABSSSI lasts four days. Children with ABSSSI, which can be life-threatening, account for 3 million pediatric visits to doctors or emergency rooms annually.

In a clinical trial, 97.3% of pediatric patients (from newborns to less than 18 years of age) receiving a single dose of Dalvance had an early clinical response to treatment compared to 86.7% of patients receiving a current standard of care. Safety data was similar to that seen in adults receiving Dalvance.

Recommended dosing is based on individual patient factors, including age and creatinine clearance (a measure of kidney health). Dalvance is administered over the course of 30 minutes via intravenous infusion. Adults can receive either a single- or a two-dose regimen, with doses given one week apart for a two-dose regimen. Only a single-dose regimen is FDA approved for pediatric patients.

The FDA first approved Dalvance in 2014.

The U.S. FDA has approved Rezipres® (ephedrine hydrochloride injection), manufactured by Eton Pharmaceuticals, to treat clinically important hypotension occurring in the setting of anesthesia.

Hypotension, or low blood pressure, can occur under anesthesia due to factors such as blood loss or anesthesia side effects. It can put patients at risk regardless of whether they receive general anesthesia, in which a patient is unconscious during a procedure, or anesthesia that prevents pain without rendering a patient unconscious, such as an epidural used for C-sections.

In clinical studies, ephedrine produced increases in blood pressure in patients under general anesthesia or neuraxial anesthesia – when local anesthetics are used around the nerves of the central nervous system. Examples of neuraxial anesthesia include epidural, spinal, and caudal anesthesia.

Recommended dosing is an initial dose of 4.7mg to 9.4mg of Rezipres administered by intravenous (IV) bolus (a rapid IV injection) followed by additional boluses as needed. Dosage should be titrated according to the blood pressure goal. Total dosage should not exceed 47mg.

Launch and pricing information are not yet available.

Viona Pharmaceuticals, Inc., has recalled two lots of Metformin Hydrochloride Extended- Release Tablets, USP 750mg due to the detection of N-nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Cadila Healthcare Limited manufactured the product in November 2019 for Viona to distribute.

NDMA is considered a probable human carcinogen (a substance that could cause cancer) and is a known environmental contaminant found in water and food. According to the recall announcement, patients who may have the affected metformin in their possession should not stop taking their medication without consulting a healthcare professional. The risk of stopping treatment with metformin, which is used to treat type 2 diabetes, may outweigh the risk of potential NDMA exposure. As of the date of the recall, Cadila and Viona had not received reports of adverse events related to the affected product.

Consumers can direct questions regarding the recall to Eversana Life Science Services at 1-888-304-5022 (option 1). They should contact their healthcare provider if they’ve experienced any problems that may be related to using the product and can also direct medical-related questions or report adverse events or quality issues to Viona at 1-888-304-5011. Adverse events can be reported to the U.S. FDA through the agency’s MedWatch program.

A full copy of the recall announcement with details of the affected lots is available on the FDA’s website.

There is no member impact through Benecard Central Fill.

The U.S. FDA has approved an expanded indication for Zipsor® (diclofenac potassium), manufactured by Assertio Therapeutics, to provide relief of mild to moderate acute pain in patients who are at least 12 years old. Zipsor first received FDA approval in 2009 for use in adults.

While diclofenac potassium, the active pharmaceutical ingredient (API) of Zipsor, is available as an API in other drugs, Zipsor comes in a proprietary, immediate release, liquid-filled gelatin capsule 25mg dosage form. It is not interchangeable with other dosage strengths or formulations of oral diclofenac potassium.

Recommended dosing is one capsule taken by mouth four times daily. A black box warning cautions that nonsteroidal anti-inflammatory drugs (NSAIDs) such as Zipsor can increase the risk of serious, potentially fatal cardiovascular and gastrointestinal (GI) events such as heart attack, stroke, GI ulcers and bleeding, and perforation of the stomach or intestines.