Company: Able Laboratories Inc.
Product: Lithium, methylphenidate, phentermine and other drugs
Date: 4/19/04
The MedWatch forms which you submitted were on FDA form 3500, which is for the voluntary reporting of ADEs by healthcare workers and consumers. As a drug manufacturer, you must be reporting all domestic ADEs on FDA MedWatch form 3500A. Reports of foreign adverse drug events may be either reported on a MedWatch form 3500A or a CIOMS form. In addition, you may use a computer generated FDA form 3500A or alternate format as specified by 314.80 (f) (3). When using form 3500A, in addition to having an identifiable patient, at a minimum this report must also include an outcome, the identifiable reporter of the ADE, as well as the suspect drug. It is also required that you list the date of the report (Box 84) and the date received by the manufacturer (Box G4). It is also necessary to conduct follow up investigations if relevant information is missing from the initial MedWatch report. All follow-up information must be included on a form 3500A, or the alternative forms cited above, and linked to the initial report by a common unique manufacturing report number.
FDA District: New Jersey District Office
