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  • Syndax announces FDA approval of Revuforj (revumenib)

    Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Revuforj revumenib as the first and only menin inhibitor for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene KMT2A translocation in adult and pediatric patients one year and older.
  • Iterum Therapeutics receives USFDA approval of ORLYNVAH (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
    Iterum Therapeutics plc announced that the U.S. Food and Drug Administration has approved Iterums new drug application for ORLYNVAH for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
  • U.S Food and Drug Administration looking for Pharmacologist / Toxicologist
    As a Pharmacologist, Toxicologist, the incumbent is responsible for reviewing and evaluating drug applications and communicating conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology, toxicology or clinical drug review divisions located within OND.
  • FDA approves Drug with New Mechanism of Action for Treatment of Schizophrenia

    The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.

  • FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

    The U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age.

  • Alembic Pharmaceuticals announces USFDA Final Approval for Albendazole Tablets USP, 200 mg

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India.

  • Strides receive USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg
    Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food & Drug Administration
  • Eugia Pharma receives warning letter from FDA

    Eugia Pharma  receives a warning letter from FDA which summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

    U.S. Food and Drug Administration (FDA) inspected a drug manufacturing facility of Eugia Pharma Specialities Limited (Unit III), at Patancheru (Mandal), Sangareddy, Hyderabad, Telangana, from January 22 to February 2, 2024. It is a wholly owned subsidiary of the Aurobindo Pharma.

  • Indoco Remedies receives ANDA approval from USFDA for Lofexidine

    Indoco Remedies receives final ANDA approval from the USFDA  for Lofexidine Tablets 0.18 mg with Competitive Generic Therapy designation, It is a generic equivalent of Lucemyra Tablets, 0.18 mg of USWM, LLC.

  • Alembic Pharmaceuticals receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

    Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India.

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