Posts in category: Uncategorized

The U.S. FDA has approved Mylan’s generic for Restasis® (cyclosporine ophthalmic emulsion) 0.05% single-use vials.

• Like Restasis, the generic is indicated to increase tear production when that production is believed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye).
• Recommended dosing is one drop in each eye twice daily, approximately 12 hours apart.
• Brand name Restasis is manufactured by Allergan and first received FDA approval in 2002. It has a wholesale acquisition cost (WAC) of $645.63 per month. Mylan’s generic is available at a WAC of $588.82 per month.

FDA approves Xenoview (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation

Polarean Imaging plc, the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted approval for its drug device combination product, Xenoview. Xenoview, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (“MRI”) for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Xenoview has not been evaluated for use with lung perfusion imaging.

Xenoview expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of Xenoview, created through the Polarean HPX hyperpolarization system, is administered in a single 10-15 second breath hold MRI procedure.

More than 30 million Americans suffer from a chronic lung disease, and there is a significant unmet need for non-invasive diagnostic technology. Xenoview can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease.

Xenoview is not approved for use in pediatric patients less than 12 years of age.

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Solosec® (secnidazole – Lupin Pharmaceuticals) now has an expanded indication to treat bacterial vaginosis and trichomoniasis in patients who are at least 12 years old.

• Solosec has been FDA approved for use in adults since 2017. Bacterial vaginosis describes inflammation in the vagina caused by bacterial overgrowth, while trichomoniasis is a sexually transmitted infection caused by a protozoan parasite.
• Recommended dosing is a single 2g packet of granules taken once by mouth, mixed with applesauce, yogurt, or pudding. If Solosec is being used to treat trichomoniasis, all sexual partners should receive the same dose at the same time.

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.