Drug Approval | March 10, 2025
Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%
Ketoconazole shampoo is an antifungal medication used to treat dandruff
Ketoconazole shampoo is an antifungal medication used to treat dandruff
USFDA inspection at Alembic Pharma's Bioequivalence facility
Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The observations issued are neither repeated observations nor related to data integrity
USFDA inspection at Emcure Pharmaceuticals API facility
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
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