Drug Approval | 07 March 2025
Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US
Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals
Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals
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 approval marks Venus Remedies’ strategic entry into complex generics, expanding its injectable portfolio beyond traditional formulations
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
Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The inspection was successfully completed
the inspection conducted from January 27 to January 31, 2025
Observations are largely around improvement of procedures and practices
The Alathur facility specializes in the production of Cephalosporin antibiotics
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries
Approval is based on positive data from the Phase 3 ECHELON-3 trial
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