Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The filing is backed by positive Phase 3 results recently published in JAMA Neurology
After a volatile decade in which approvals swung sharply from year to year, 2025’s total pushed past long-term norms, exceeding the 10-year average
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Pharmaceutical R&D veteran brings over 20 years of expertise in formulation development, ANDA filings, and regulated-market product innovation to strengthen MSN Laboratories’ global growth ambitions
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
The filing is backed by Phase III data from the lidERA Breast Cancer study
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