GENERIC DRUG APPROVALS

July 2024

  • Indium In-111 Pentetreotide Injection Kit 3 mCi/mL
    Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
    Used for: Diagnosis and Investigation
    Generic for: Octreoscan
  • Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL
    (13.3mg/mL)
    Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
    Used for: Analgesia
    Generic for: Exparel

June 2024

  • Palbociclib Tablets 75mg, 100mg and 125mg
    Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
    Treatment for: Breast Cancer
    Generic for: Ibrance Tablets
  • Avanafil Tablets 50mg, 100mg and 200mg
    Approved: June 14, 2024 – Hetero Labs Limited
    Treatment for: Erectile Dysfunction
    Generic for: Stendra
  • Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg,
    7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
    Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
    Treatment for: Obesity
    Generic for: Qsymia

KISUNLA™

FDA Approves Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has approved Kisunla™ (donanemab-azbt, 350mg/20mL injection for IV infusion) as treatment of early symptomatic Alzheimer’s disease (AD) which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

  • Once-monthly Kisunla IV infusion is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.
  • Among the overall population of Phase 3 study participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.
  • The FDA’s dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging.

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FDA Gives Nod to RSV Vaccine for People in Their 50s

Medically reviewed by Drugs.com.
By Ernie Mundell HealthDay Reporter

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

  • Drugmaker GSK’s Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already
    approved for use in adults 60 and older, since age brings higher risk from RSV disease.
  • Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

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FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Causedby RSV

The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

  • The approval was granted under a breakthrough therapy designation and marks the second
    approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as
    the Moderna COVID-19 vaccines.
  • Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025
    respiratory virus season.
    Source: Moderna, Inc.

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MYHIBBIN™

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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