AUGUST

• Trametinib Dimethyl Sulfoxide Tablets 0.5mg (base) and 2mg (base)
  Approved: August 6, 2024 – Novugen Pharma (USA) LLC
  Treatment for: Cancer
  Generic for: Mekinist
• Lofexidine Hydrochloride Tablets 0.18mg (base)
  Approved: August 20, 2024 – Indoco Remedies Ltd.
  Treatment for: Opiate Withdrawal
  Generic for: Lucemyra
• Riluzole Oral Suspension 50mg/10mL
  Approved: August 22, 2024 – Alkem Laboratories Ltd.
  Treatment for: Amyotrophic Lateral Sclerosis
  Generic for: Tiglutik
• Methylnaltrexone Bromide Subcutaneous Solution 8mg/0.4mL and 12mg/0.6mL
  Approved: August 26, 2024 – Actavis Pharma, Inc.
  Treatment for: Opioid-Induced Constipation
  Generic for: Relistor
• Amantadine Hydrochloride Extended-Release Capsules 68.5mg (base)
  Approved: August 26, 2024 – Zydus Pharmaceuticals (USA) Inc.
  Treatment for: Parkinson’s Disease
  Generic for: Gocovr