New Drug/Vaccine Approval

Sofdra™ (sofpironium) Topical Gel – New Drug Approval – June 18, 2024 – Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Administration (FDA) approval of Sofdra™ (sofpironium) gel, 12.45%. Sofdra™ is a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and older. <Read More> Capvaxive™ (pneumococcal 21-valent conjugate vaccine) Injection - formerly V116 – New Vaccine Approval – June 17, 2024 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Capvaxive™ (Pneumococcal 21-valent Conjugate Vaccine)… Capvaxive™ is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. The approval follows the FDA’s Priority Review of Merck’s application. Do not administer Capvaxive™ to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of Capvaxive™ or to diphtheria toxoid. <Read More> Vigafyde™ (vigabatrin) Oral Solution – New Drug Approval – June 17, 2024 – Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vigafyde™, the only ready-to-use vigabatrin oral solution. Vigafyde™ (vigabatrin) oral solution, is indicated as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss. <Read More> Yimmugo® (immune globulin intravenous, human-dira) Liquid for Intravenous Injection – New Drug Approval – June 13, 2024 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID). <Read More>  Iqirvo® (elafibranor) Tablets – New Drug Approval – June 10, 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo® may be prescribed immediately in the U.S. for eligible patients. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. <Read More>

New Indication/Dosage/Formulation Approval

Krazati (adagrasib) Tablets – New Label Expansion – June 21, 2024 – The Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. <Read More> Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection – New Label Expansion – June 21, 2024 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart® Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP. <Read More> Elevidys® (delandistrogene moxeparvovec-rokl) Suspension for Intravenous Infusion – New Label Expansion – June 20, 2024 – Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced U.S. Food and Drug Administration (FDA) approval of an expansion to the labeled indication for Elevidys® (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. Confirming the functional benefits, the FDA granted traditional approval for ambulatory patients. The FDA granted accelerated approval for non-ambulatory patients. <Read More> Skyrizi® (risankizumab-rzaa) Injection – New Label Expansion – June 18, 2024 – AbbVie (NYSE: ABBV) announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease. Skyrizi® is now approved for four indications across immune-mediated inflammatory diseases. <Read More> Keytruda® (pembrolizumab) for Injection – New Label Expansion – June 17, 2024 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada,  announced the U.S. Food and Drug Administration (FDA) has approved Keytruda®, Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by Keytruda® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. This approval marks the third endometrial carcinoma indication and the 40th indication overall for Keytruda® in the U.S. <Read More> Blincyto® (blinatumomab) Injection – New Label Expansion – June 14, 2024 – The Food and Drug Administration approved blinatumomab (Blincyto®, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. <Read More> Imfinzi® (durvalumab) Injection – New Label Expansion – June14, 2024 – The Food and Drug Administration approved durvalumab (Imfinzi®, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). <Read More> Augtyro™ (repotrectinib) Capsules – New Label Expansion – June 14, 2024 – The Food and Drug Administration granted accelerated approval to repotrectinib (Augtyro™, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. <Read More> Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets and Farxiga® Tablets– New Label Expansion – June 12, 2024 – AstraZeneca’s Farxiga® (dapagliflozin) and Xigduo® XR (dapagliflozin and metformin hydrochloride) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval was based on positive results from the pediatric T2NOW Phase III trial. Farxiga® was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycemic control. <Read More> Adbry® (tralokinumab-ldrm) Injection – New Label Expansion – June 12, 2024 – LEO Pharma Inc. has announced approval from the U.S. Food and Drug Administration (FDA) for a new Adbry® (tralokinumab-ldrm) 300 mg single-dose autoinjector for adult patients. Adbry®, a high-affinity fully human monoclonal antibody, is currently indicated in the U.S. for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older. The new autoinjector will provide another option for adult patients in addition to the pre-filled syringe administration that is currently available. <Read More> Retevmo® (selpercatinib) Capsules and Tablets – New Label Expansion – June 12, 2024 - the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo®, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. <Read More> Kevzara® (sarilumab) Injection – New Label Expansion – June 10, 2024 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. <Read More>

New Drug Shortage

June 14, 2024

• Fluconazole Tablet (Discontinuation)

Updated Drug Shortage

June 24, 2024

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Penicillin G Benzathine Injection (Currently in Shortage)

June 18, 2024

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Methotrexate Sodium Tablet (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Sucralfate Tablet (Currently in Shortage)

June 17, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bumetanide Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Cefotetan Disodium Injection (Currently in Shortage)

• Chloroprocaine Hydrochloride Injection (Currently in Shortage)

• Cisplatin Injection (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dacarbazine Injection (Currently in Shortage)

• Dexamethasone Sodium Phosphate Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Leucovorin Calcium Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lidocaine Hydrochloride Solution (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Remifentanil Hydrochloride Injection (Currently in Shortage)

• Rifampin Injection (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Ropivacaine Hydrochloride Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sodium Chloride 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Valproate Sodium Injection (Currently in Shortage)

• Vinblastine Sulfate Injection (Currently in Shortage)

June 13, 2024

• Atropine Sulfate Injection (Currently in Shortage)

• Bupivacaine Hydrochloride Injection (Currently in Shortage)

• Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently in Shortage)

• Carboplatin Injection (Currently in Shortage)

• Clindamycin Phosphate Injection (Currently in Shortage)

• Cytarabine Injection (Currently in Shortage)

• Dexmedetomidine Hydrochloride Injection (Currently in Shortage)

• Dextrose Monohydrate Injection (Currently in Shortage)

• Dobutamine Hydrochloride Injection (Currently in Shortage)

• Dopamine Hydrochloride Injection (Currently in Shortage)

• Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Currently in Shortage)

• Epinephrine Injection, Syringes (Currently in Shortage)

• Etomidate Injection (Currently in Shortage)

• Fentanyl Citrate Injection (Currently in Shortage)

• Furosemide Injection (Currently in Shortage)

• Gentamicin Sulfate Injection (Currently in Shortage)

• Heparin Sodium Injection (Currently in Shortage)

• Hydrocortisone Sodium Succinate Injection (Currently in Shortage)

• Hydromorphone Hydrochloride Injection (Currently in Shortage)

• Ketamine Hydrochloride Injection (Currently in Shortage)

• Ketorolac Tromethamine Injection (Currently in Shortage)

• Lidocaine Hydrochloride Injection (Currently in Shortage)

• Lorazepam Injection (Currently in Shortage)

• Methotrexate Sodium Injection (Currently in Shortage)

• Methylprednisolone Acetate Injection (Currently in Shortage)

• Midazolam Hydrochloride Injection (Currently in Shortage)

• Morphine Sulfate Injection (Currently in Shortage)

• Potassium Acetate Injection (Currently in Shortage)

• Quinapril Hydrochloride Tablet (Currently in Shortage)

• Quinapril/Hydrochlorothiazide Tablet (Currently in Shortage)

• Rocuronium Bromide Injection (Currently in Shortage)

• Sodium Acetate Injection (Currently in Shortage)

• Sodium Bicarbonate Injection (Currently in Shortage)

• Sodium Chloride 0.9% Injection (Currently in Shortage)

• Sodium Chloride 14.6% Injection (Currently in Shortage)

• Sodium Chloride 23.4% Injection (Currently in Shortage)

• Sodium Phosphate, Dibasic, Anhydrous, Sodium Phosphate, Monobasic, Monohydrate Injection (Currently in Shortage)

• Somatropin Injection (Currently in Shortage)

• Sterile Water Injection (Currently in Shortage)

• Sufentanil Citrate Injection (Currently in Shortage)

June 11, 2024

• Hydroxocobalamin Injection (Currently in Shortage)

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

The High-Shortage Generic Market – June 22, 2024 – The Senate Committee on Finance released a bipartisan draft addressing drug shortages, focusing on low-margin generic sterile injectables crucial for hospitals. ASHP reported an all-time high of 323 drug shortages in March, many being generics. The top shortage classes in early 2024 included antimicrobials, chemotherapy, CNS drugs, fluids/electrolytes, and hormonal agents, with 118 out of 200 being sterile injectables. The legislation targets group purchasing organizations (GPOs) controlling 90% of the market, as their low-price contracts hinder manufacturers' ability to invest in quality and capacity, leading to shortages. <Read More> Biden’s Plan to Save Money on Medicare Drugs Risks Leaving Shelves Empty, Pharmacists Say – June 11, 2024 – Months into a new Biden administration policy intended to lower drug costs for Medicare patients, independent pharmacists say they’re struggling to afford to keep some prescription drugs in stock. “It would not matter if the governor himself walked in and said, ‘I need to get this prescription filled,’” said Clint Hopkins, a pharmacist and co-owner of Pucci’s Pharmacy in Sacramento, California. “If I’m losing money on it, it’s a no.” A regulation that took effect in January changes prescription prices for Medicare beneficiaries. For years, prices included pharmacy performance incentives, possible rebates, and other adjustments made after the prescription was filled. Now the adjustments are made first, at the pharmacy counter, reducing the overall cost for patients and the government. But the new system means less money for pharmacies that acquire and stock medications, pharmacists say. <Read More> 17 Million US Adults May No Longer Receive Statin Therapy for Heart Disease – June 14, 2024– Doctors have to make tough choices about prescribing medications, weighing the potential risks and benefits. They typically use official recommendations from governing bodies and relevant medical organizations to help guide their clinical practice recommendations.Groups update these guidelines based on components like newly available data. Researchers want to understand how these guideline changes affect clinical practice and medication recommendations.A study recently published in JAMA Internal MedicineTrusted Source looked at two equation sets to measure 10-year atherosclerotic cardiovascular disease risk and how they affected primary prevention statin therapy recommendations. <Read More> FDA Plans to Ease Requirements for Biosimilars' Interchangeable Status—New Rules Would Mean Switching Studies Will Generally Not Be Needed – June 20,2024 – The FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded reference product does not present any potential safety risks or risk of diminished efficacy. In new draft guidanceopens in a new tab or window, the agency is suggesting a "revised approach where such studies will generally not be needed". Any physician can prescribe a biosimilar in place of a branded reference product, but the interchangeable status brings the advantage of being able to be substituted without need for a prescription change at the pharmacy level in some states, similar to generic drugs. <Read More> Study Shows That Clinical Decision Support Software Can Prevent 95% of Medication Errors in the Operating Room – June 13, 2024 – A Massachusetts General Hospital study found that clinical decision support software can prevent 95% of medication errors in the OR, as reported in Anesthesia & Analgesia. This software provides evidence-based information to clinicians, enhancing decision-making and preventing errors. "Medication errors in the operating room have high potential for patient harm," said senior author Dr. Karen C. Nanji. Despite its effectiveness in improving efficiency and quality of care, adoption of this technology is still in its early stages. Embedded Specialty Pharmacist Improves Therapy Access in Dermatology Clinic – June 12, 2024 – Embedding a specialty clinical pharmacist into a dermatology clinic significantly improved the number of patients initiated on therapy and cut the time from receiving an insurance prior authorization (PA) denial to submitting an appeal by almost two weeks, according to presentation at the ASHP Pharmacy Futures meeting (poster 13M).The University of Kansas Health System, in Kansas City, began embedding a clinical pharmacist in its dermatology clinic in 2021, sooner than for many of its other specialty clinics. The older system of pharmacy patient advocates in its specialty pharmacy had assisted with benefits eligibility for dermatology patients, and a pharmacist working within the specialty pharmacy had called patients to conduct education and assess the appropriateness of initiating specialty medications.  “The embedded pharmacist does in-person patient education and collaborates with providers on obtaining coverage,” said presenting author Lydia Ganaden, PharmD, a PGY-2 pharmacy resident. “She has definitely expanded our services in dermatology.” <Read More>

340B in the News

Protecting the 340B Program Vital for Providing the Best Care to Patients With HIV – June 21, 2024 – Legislation that could change the 340B program should be done so with caution, as the federal program acts as a boon to care for patients with HIV, experts argue. The 340B Drug Pricing Program was first created in 1992 to protect hospitals in safety-net areas from the increasing prices of drugs. Experts working in clinics that benefit from the 340B Program have emphasized how important the program is for them to continue their work in providing health care to patients of vulnerable populations, including patients with HIV, due to the funding that it provides for them to maintain the clinic services. In February 2024, 6 senators, both Republican and Democrat, released a draft bill titled "Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act" (SUSTAIN 340B Act) with an aim of codifying the functions of the 340B program into federal law.<Read More>