Since approving the generic IV iron medicine in March 2011, FDA has approved several other generic complex drugs, including a generic version of a drug that fights several types of cancer, called ...

Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug ...

The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

Generic drugs account for more than 90% of prescriptions filled in the United States. The Food and Drug Administration insists that they “have the same high quality, strength, purity and stability as ...

A CDSCO panel has recommended waiving local Phase III clinical trials and bioequivalence studies for lenacapavir ...

Sunshine Biopharma Inc. (NASDAQ: SBFM) announced on Wednesday that it has secured regulatory approval to introduce its generic Enalapril tablets across the Canadian market, signaling a significant ...

In a significant development for diabetes treatment, Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for its generic version of dapagliflozin tablets, ...

The FDA has approved a generic version of fluticasone propionate (marketed as Flovent HFA), according to a statement issued on March 3. The approval extends the accessibility of the medication, ...