Posts in category: Uncategorized

• Arestin (minocycline hydrochloride) – for gum disease
• Abraxane (paclitaxel) – for cancer
• Cholbam (cholic acid) – for bile acid synthesis disorders and peroxisomal disorders
• Revlimid 5mg, 10mg, 15mg, 25mg (lenalidomide) – for cancer
• Vimpat (lacosamide) – for seizures
• Zipsor (diclofenac potassium) – for pain relief

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.

Vonjo™ (pacritinib) has received U.S. FDA approval to treat intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis in adults who have a platelet count below 50 × 10⁹/L.

• Vonjo is a novel oral kinase inhibitor that acts against enzymes in the body that may contribute to myelofibrosis, a rare bone marrow cancer. In myelofibrosis, scar tissue replaces healthy bone marrow and interferes with production of red blood cells, white blood cells, and platelets.
• Recommended dosing is two 100mg capsules taken twice daily by
• CTI BioPharma, the manufacturer, has announced that Vonjo will be available at a wholesale acquisition cost (WAC) of $19,500 per month.

February 24, 2022 – Jardiance® (empagliflozin – Boehringer Ingelheim) is now indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults who have heart failure.

• Initially FDA approved in 2014, Jardiance is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes, and to reduce the risk of cardiovascular death in adults who have type 2 diabetes and established cardiovascular disease.
• Recommended dosing is 10mg once daily in the morning. For adults who have type 2 diabetes and require additional glycemic control, the dose can be increased to 25mg per day.

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.

Read more…

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.

Read more…

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.