USFDA

Pharma Courses  
  • FDA rejects Otsuka and Lundbeck’s bid for REXULTI® in PTSD Treatment
    23 September 2025

    FDA rejects Otsuka and Lundbeck’s bid for REXULTI® in PTSD Treatment

    Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for the use of REXULTI® (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD).
  • 23 September 2025
    FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
    U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria.
  • 23 September 2025
    FDA moves to approve Leucovorin Calcium for rare neurological disorder linked to Autism

    The U.S. Food and Drug Administration (FDA) has taken a significant step forward in approving leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD) — a rare neurological condition that disrupts the transport of folate, a vitamin essential for brain development and function.

    Cerebral folate deficiency has been associated with developmental delays, seizures, coordination problems, and autistic features such as challenges in social communication, sensory issues, and repetitive behaviors.

  • 20 September 2025
    USFDA successfully completes inspection at Indoco’s API manufacturing facility at Patalganga with zero observations
    Indoco Remedies Limited announced that the United States Food and Drug Administration successfully completed inspection of its Active Pharmaceutical Ingredients (API) manufacturing facility at Patalganga, Navi Mumbai. The inspection concluded with zero form 483 observations, reflecting the company's commitment to the highest standards of quality, regulatory compliance and operational excellence.
  • 4 September 2025
    Caplin Steriles Gets USFDA approval for Milrinone Lactate In 5% Dextrose Injection, Infusion Bags
    Caplin Steriles Limited has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC.
  • 4 September 2025
    Lupin receives USFDA approval for Risperidone Long-Acting Injectable
    Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.
  • 30 August 2025
    FDA approves Teva's generic Weight loss medicine of Saxenda
    Teva Pharmaceuticals, Inc. announced the FDA approval and U.S. launch of a generic version of Saxenda, liraglutide injection. first-ever generic GLP-1 indicated for weight loss
  • 29 August 2025
    FDA recommends more MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)

    The U.S. Food and Drug Administration (FDA) is recommending an additional, earlier magnetic resonance imaging (MRI) monitoring prior to the 3rd infusion for patients with Alzheimer’s disease taking Leqembi (lecanemab). The earlier monitoring can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or fluid buildup. ARIA-E is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur and there have been deaths.

  • 19 August 2025
    Alembic Pharmaceuticals Limited announces USFDA Final approval for Macitentan Tablets, 10 mg
    Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg.
  • 19 August 2025
    Novo Nordisk Wegovy approved in the US for the treatment of MASH
    The U.S. Food and Drug Administration has approved Wegovy (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver).
Subscribe to USFDA