FDA generic drug approvals hit record high in July

The FDA approved or tentatively approved 126 generic drugs in July — more than any other month in history, according to Regulatory Focus.

There were 96 generic drugs approved and 30 generic drugs tentatively approved. This sharp increase in approvals for generics follows five months of declining generic approvals.

More competition from generics is thought to be a critical component of lowering drug prices.

In July, the FDA also sent an annual high of 357 complete response letters, which are sent to companies to communicate that the agency has completed its review of a new or generic drug application and it will not approve the generic in its present form.

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