Dogma says that a compound used for a nutrition, such as a vitamin, cannot be a drug. Such dogma prevents the development of many good drugs. The FDA just approved vitamin C – ascorbic acid as a drug. Read on to learn how this came about. Afterward, challenge yourself to think about other situations where […]Read More
Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug?
Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug? As the 505(b)(2) expert, Camargo is exposed to many projects in which Sponsors have attempted to leverage the 505(b)(2) pathway as a way to utilize information obtained from studies not conducted by or for the Sponsor. For the […]Read More
UNFORCED ERRORS: FDA Refusal to File or Receive Letters Few things can be more damaging to a pharmaceutical company than the refusal by the Food and Drug Administration (FDA) to review their New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). When a company submits their application for authorization to market a new or […]Read More
A New Indication for an Old Drug. What Could Go Wrong? Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus, hemophilia A, type 1 von Willebrand’s disease, nocturnal enuresis (bedwetting) in children, and as a diagnostic test to measure renal concentrating abilities. Desmopressin […]Read More
On May 27th, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the FDA for their sodium zirconium cyclosilicate (ZS-9) New Drug Application (NDA) (reference link). This hyperkalemia drug was developed by ZS Pharma and was generally expected to receive FDA approval when AstraZeneca acquired the company for $2.7 billion last year. Instead […]Read More