MONTHLY HIGHLIGHTS ON 505(b)2 AND LOW COMPETITION GENERICS
In July 2019, total four 505(b)2 products were approved by USFDA. Two of them were injectable (namely Zinc sulphate injection and Bivalirudin solution); while other two were orals (namely Duloxetine sprinkle and Amlodipine suspension).
The summary also covers difference between the existing dosage form and newly approved 505(b)2 dosage form for e.g. difference between Drizalma™ sprinkle and existing Cymbalta™ has been highlighted.
In case of low competition generics, three ANDAs were approved by USFDA whose corresponding RLDs were mentioned in FDA’s list of off-patent off-exclusivity products without an approved generic.
Below is summary of these products:
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