Drug Approval | January 25, 2023
Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Granules now have a total of 53 ANDA approvals from USFDA
Granules now have a total of 53 ANDA approvals from USFDA
This is the sixth successful USFDA audit for this facility
It has a total of 50 ANDA approvals from USFDA
The audit is a PAI for two of its product applications filed from this facility
Potassium chloride is used to prevent or to treat low blood levels of potassium
The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
Acute therapies continue to report strong growth compared to chronic ones.
The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
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