Drug Approval | October 19, 2022
USFDA visit to Alembic Pharmaceuticals Panelav facility
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
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 product will be manufactured at Lupin's facility in Nagpur, India.
The inspection concluded with no observation (FDA-483) issued.
Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
The inspection of the facility was conducted from August 16-19, 2022.
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