Drug Approval | October 27, 2022
USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
The CRL did not identify any outstanding scientific issues with the product.
The CRL did not identify any outstanding scientific issues with the product.
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
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
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
The inspection concluded with no observation (FDA-483) issued.
The product will be manufactured at Lupin's facility in Nagpur, India.
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