Posts in category: News

By Dennis Thompson, HealthDay Reporter; Medically reviewed by Drugs.com

Researchers say they’ve identified a human “neural compass” — a pattern of brain activity that helps prevent humans from becoming lost.

This discovery could increase understanding of diseases like Alzheimer’s and Parkinson’s, in which a person’s navigation and orientation are frequently impaired.

Future research will take these findings a step further, to figure out how the brain navigates through time and whether this brain activity is related to memory.

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Dr. Reddy’s Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency.

• Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

Source: FDA

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FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

• In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
• Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
• It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

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By Dennis Thompson, HealthDay Reporter; Medically reviewed by Carmen Pope, BPharm

Artificial intelligence (AI) might be able to identify patients who have rare diseases years earlier than they would typically be diagnosed, a new study says.

• A newly developed AI program was able to successfully identify people at risk of developing a rare immune disorder, researchers report in Science Translational Medicine.
• Out of a group of 100 people judged at highest risk by the AI program, 74 very likely have the disorder, researchers found. This shows that AI could potentially improve the outcomes of these folks by getting them earlier treatment.

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Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. FDA.

The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S. market for patient use, including 2 mg and 20 mg.

Source: Otsuka America Pharmaceutical, Inc

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APRIL 2024

• Valbenazine Tosylate Capsules 40 mg (base) and 80 mg (base)
  Approved: April 5, 2024 – Lupin Pharmaceuticals, Inc.
  Treatment for: Huntington’s Disease, Tardive Dyskinesia
  Generic for: Ingrezza
• Eribulin Mesylate Intravenous Solution 1 mg/2 mL (0.5 mg/mL)
  Approved: April 5, 2024 – Gland Pharma Limited
  Treatment for: Breast Cancer, Liposarcoma
  Generic for: Halaven
• Doxycycline (Anhydrous) Immediate/Delayed Release Capsules 40 mg
  Approved: April 8, 2024 – Dr. Reddys Laboratories Inc.; Lupin Pharmaceuticals, Inc.
  Treatment for: Rosacea
  Generic for: Oracea
• Estradiol Transdermal Gel (Metered) 0.06% (1.25 g/activation)
  Approved: April 22, 2024 – Solaris Pharma Corporation
  Treatment for: Menopausal Symptoms
  Generic for: EstroGel
• Deflazacort Oral Suspension 22.75 mg/mL
  Approved: April 25, 2024 – Tris Pharma Inc.
  Treatment for: Duchenne Muscular Dystrophy
  Generic for: Emflaza Suspension
• Midostaurin Capsules 25 mg
  Approved: April 29, 2024 – Teva Pharmaceuticals USA, Inc.
  Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis
  Generic for: Rydapt

FDA Approves Ingrezza® Sprinkle (valbenazine) Capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.

Neurocrine Biosciences, Inc. has announced the FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral granules formulation of Ingrezza (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.

• Ingrezza Sprinkle provides an alternative administration option for those who experience dysphagia or
• have difficulty swallowing.
• Ingrezza (valbenazine) offers simple dosing that’s always one capsule, once daily with no complex titration. It is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers three effective dosages (40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare provider based on patient response and tolerability.

Source: Neurocrine Biosciences, Inc.

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FDA Approves Hercessi, a Biosimilar to Herceptin

Accord BioPharma, Inc., announced that the FDA has approved Hercessi™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.

• Hercessi and its reference product, Herceptin (trastuzumab), are highly similar in terms of efficacy, safety, and quality. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.

• The safety profile of Hercessi has been shown to be consistent with the safety profile for the reference
  product Herceptin. The data demonstrates that there are no clinically meaningful differences between Hercessi and Herceptin in the populations studied and support biosimilarity between the two therapies.
• Hercessi was approved by the FDA at a dosage of 150mg. A 420mg-strength version of Hercessi is also in development from Accord BioPharma, with an FDA decision anticipated in Q4 2024.

Source: Accord BioPharma

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FDA Approves Libervant™ Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

Aquestive Therapeutics, Inc. has announced that the FDA has approved Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between 2 to 5 years of age.

• In 2023, over 55,000 prescriptions were filled for patients between the ages of 2 and 5. This was an increase of 10.8% over the previous year. Prescription writing for this indication is highly concentrated among pediatric epileptologists and pediatric neurologists.
• Libervant™ is a film formulation of diazepam administered inside the cheek. Do not give Libervant™ to your child if your child is allergic to diazepam or any of the ingredients in Libervant™ or has an eye problem called acute narrow angle glaucoma.

Source: Aquestive Therapeutics, Inc.

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FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome

The FDA has approved Xolremdi™ capsules, manufactured by X4 Pharmaceuticals, for use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.

• WHIM syndrome is a rare, combined primary immunodeficiency and chronic neutropenic disorder caused by CXCR4 receptor dysfunction that results in impaired mobilization of white blood cells from the bone marrow into peripheral circulation. It is estimated that at least 1,000 people are currently diagnosed with WHIM syndrome in the U.S.

Source: X4 Pharmaceuticals

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