BeneCard PBF compiles the latest pharmacy news from across the web, including new drug approvals, recalls, new generic drug approvals and more.  The content is the property of the website owners, writers and contributors.

New Drug Approvals

Eohilia

FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

February 12, 2024 – Takeda has announced that the U.S. Food and Drug Administration has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

Eohilia is a corticosteroid indicated for 12 weeks of treatment in patients and was developed specifically for EoE. Eohilia’s novel formulation of budesonide confers thixotropic properties, thus flowing more freely when shaken and returning to a more viscous state when swallowed.

EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus. Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.

Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).

Eohilia has not been shown to be safe and effective for the treatment of EoE for Longer than 12 weeks.

Warnings and Precautions:

• Hypercorticism and Adrenal Axis Suppression
• Immunosuppression and Increased Risk of Infection

Read more at Drugs.com…

Newly Approved Indications

Onivyde Regimen

Ipsen’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma (mPDAC), Approved by the FDA

February 13, 2024 – Ipsen has announced that the U.S. Food and Drug Administration has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

This is the second approval for an Onivyde regimen in mPDAC, succeeding the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die.

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

The Napoli 3 study of the Onivyde (Nalirifox) regimen provided a statistically significant improvement in median overall survival of 11.1 months compared to 9.2 months in nab-paclitaxel and gemcitabine treatments.

Read more at Drugs.com…

Generic Drug Approvals

Deflazacort – Approved February 9, 2024

• Brand name: Emflaza
• Dosage forms: oral suspension (22.75 mg/mL), oral tablet (18 mg; 30 mg; 36 mg; 6 mg)
• Drug class: Glucocorticoids
• Deflazacort is a steroid that is used to treat Duchenne muscular dystrophy in adults and children at least 2 years old.
• Deflazacort is not a cure for muscular dystrophy, but deflazacort may improve muscle strength and slow the progression of disability.

Read more at Drugs.com…

Bromfenac (ophthalmic) – Approved February 2, 2024

• Brand names: BromSite, Prolensa, Xibrom, Bromday
• Dosage form: ophthalmic solution (0.07%; 0.075%; 0.09%)
• Drug class: Ophthalmic anti-inflammatory agents
• Bromfenac ophthalmic (for the eyes) is used to treat swelling and pain caused by cataract surgery.
• Bromfenac is a non-steroidal anti-inflammatory drug (NSAID).

Read more at Drugs.com…

Recalls
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing

January 24, 2024 –Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

To date, Azurity has not received any reports of serious adverse events related to this recall.

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Product was distributed nationwide through pharmacies.

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers that have product which is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product. Azurity has enlisted the services of Inmar Intelligence to facilitate the recall. Inmar is located at 3845 Grand Lakes Way, Grand Prairie, TX 75050. All returns from wholesalers and retailers must go to Inmar at this address.

For more information regarding this recall, please reference the following telephone numbers:

• For information regarding the recall process, call Inmar Intelligence at 877-804-2069 (Monday through Friday, 9AM-5PM EST).
• For medical or technical product information or to report a technical product complaint or adverse event please call 800-461-7449 (Monday through Friday, 9AM-5PM EST).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. An adverse event may also be reported to Azurity via email at aereports@azurity.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.