Drug Approval | March 14, 2022
USFDA approves Zydus’ Colestipol Hydrochloride tablets
It is only the second generic application approved by the USFDA
It is only the second generic application approved by the USFDA
Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg
To be marketed by Strides Pharma Inc. in the US market
TRIS AMINO HCl is widely used as a diagnostic reagent and as a downstream processing buffer in the purification of commercial biopharmaceuticals
The product will be marketed under store brand labels and is comparable to the brand Zyrtec
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
The drug is indicated for mild and transient episodes of heart block
It had an estimated market size of US $ 32 million as of June 2021
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
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