Drug Approval | October 30, 2022
USFDA issues Form 483 for Parawada unit of Laurus Labs
The observation is procedural in nature and the company will address the observation within stipulated timelines.
The observation is procedural in nature and the company will address the observation within stipulated timelines.
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.
On the Capex front, the company has invested Rs. 416 crore in the first half and it is broadly in line with our guidance for the two years around Rs. 2,000 crore across all the subsidiaries and divisions
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
High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints.
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
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