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).
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
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. For additional Zenzedi® safety information, please visit www.azurity.com.
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.
| Product | NDC No. | Lot No. | Exp. Date | Ship Dates to Manufacturers |
| Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg | 24338-856-03 | F230169A | 2025-06 | 08/23/2023 – 11/29/2023 |
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-FDA0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Merck announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.
Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation.
Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug.
The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.
To date, Leiters Health has not received any reports of adverse events related to this recall.
Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352.
Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.
The products were distributed nationwide to hospitals for administration in the hospital. Leiters Health has notified its customers by a letter; sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have a product which is being recalled should cease using it and return it to Leiters Health.
Consumers with questions regarding this recall can contact Leiters Health by phone at 1-800-292-6772 or email at recall@leiters.com Monday through Friday between 8:00 AM MST and 5:30 PM MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Customers will receive return shipping labels for phenylephrine and vancomycin returns via email from Leiters Health, to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112. Customers will receive return shipping labels, along with a DEA Form 222, for fentanyl returns via mail from Leiters Health, to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112.
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
FDA Approves Zelsuvmi (berdazimer topical gel) for the Treatment of Molluscum Contagiosum
Ligand Pharmaceuticals Incorporated has announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (MC) in adults and pediatric patients one year of age and older. The FDA approved Zelsuvmi as the first novel drug for the treatment of molluscum infections.
Zelsuvmi is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or other medical setting to treat this highly contagious viral skin infection.
Molluscum is a highly contagious viral skin infection characterized by skin-colored to red lesions with a central, umbilicated viral core. Approximately 6 million Americans, primarily children, are infected each year. However, up to 73% of children go untreated. Treating the lesions is critical to preventing the viral infection from spreading to other people or to other areas of the body.
Zelsuvmi is expected to be available in the United States in the second half of 2024.
Author: Melody L. Berg, PharmD, BCPS, MPH/ Medically reviewed by Carmen Pope, BPharm.
Biologic or biosimilar drug, what is the difference?
Much like a generic is similar to the brand-name drug, each biosimilar drug is similar to an already- approved biologic drug. Biologic drugs are developed through a complex process that utilizes sugars, proteins, cells, or tissues from humans, animals, or microorganisms. There are many biologics on the market, and they are used to treat several medical conditions.
Examples of commonly used biologics are adalimumab (Humira®) to treat rheumatoid arthritis and psoriasis, epoetin (Epogen® or Procrit®) to increase red blood cell production in the body, and trastuzumab (Herceptin®) to treat breast cancer. Making medications from living cells is a very complicated process and requires a large investment of time and money. That’s why biologics can be expensive. The average daily cost for a biologic is more expensive vs. a non-biologic medication.
Biosimilar drugs are very similar to, but are not exact copies of, the original biologic drug in the way the product is made. However, biosimilars produce equivalent clinical outcomes to that of the original biologic, and they cost less.
Biosimilars have been compared to generic drugs. However, there are several important differences between these types of medications. Generic medications are exact copies of the original drug product with the exact same active ingredient and name. Biosimilars, on the other hand, work the same way as the original biologic medications but are not exact copies of the original medication.
The FDA requires all biosimilar medications to be approved for safety and effectiveness. Current state laws require biosimilars to be specifically prescribed for you by a doctor or other healthcare prescriber. Someday, pharmacists may be allowed to switch prescriptions from a biologic to a biosimilar if it is cost-effective for the patient.
Although biosimilars are new to the United States, they have been offered to patients in Europe for almost a decade. Biosimilars have the potential to drive down drug costs, saving the healthcare system billions of dollars and providing lower-cost treatment options for patients. Be on the lookout for new biosimilars in the near future.
Learn more about biosimilar medications.
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.
Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML) in adults and children who are at least 1 year old. Nilotinib is usually taken every 12 hours on an empty stomach.
Nilotinib can cause a serious heart problem, especially if you use certain other medicines at the same time. Nilotinib is usually given after other treatments have failed.
FDA Approves Wainua (eplontersen) for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
Ionis Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca’s Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.
U.S. FDA approval based on Phase 3 NEURO-TTRansform results showing Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy impairment and quality of life.
ATTRv-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade. Wainua is a ligand-conjugated antisense oligonucleotide (LICA) medicine designed to reduce the production of TTR protein at its source. Wainua will be available in the U.S. in January 2024. Additional regulatory reviews for Wainua are underway in the rest of world.
FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa
Chiesi Global Rare Diseases, a business unit of the Chiesi Group has announced that the U.S. Food and Drug Administration (FDA) approved Filsuvez® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).
Filsuvez is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of epidermolysis bullosa (EB) with blisters beginning in infancy. Filsuvez joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year.
EB is a debilitating inherited skin disease that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow healing wounds at risk of infection and painful dressing changes.
Filsuvez is administered at home, allowing for integration into existing treatment routines. Filsuvez is applied topically to the wound at each dressing change.
FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
GC Biopharma Corp has announced that the U.S. Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “GC5107,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).
Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body’s ability to produce antibodies is impaired, affecting the immune system’s ability to fight infections. In PI, there’s a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G, leading to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. People with PI might experience frequent infections, some of which can be severe or chronic. Treatment often involves immunoglobulin replacement therapy to boost the immune system.
Vaccinations and antibiotics may also be used to prevent and treat infections. The exact type and severity of PI can vary widely among individuals.
Benecard Association
