Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022
Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.
Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.
The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.
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