Drug Approval | October 27, 2022
Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
The CRL did not identify any outstanding scientific issues with the product.
Oncodesign Services (ODS ), with 600 clients in 33 countries and 227 employees worldwide, provides services from target identification to hit-to-lead and lead optimization through to IND filing.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint
The new plant will include a wide range of dosage form capabilities for oral solids, liquids, topicals, films, and manufacturing technologies for granulation, film coating, spray drying, tableting
A well researched and affordable fixed dose combination, which will significantly improve the glycemic control in adult patients suffering from uncontrolled Type 2 diabetes, especially the ones with comorbidities
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