Roberts eliminates backlog of annual reports cited in FDA warning letter.

ROBERTS ANNUAL REPORT BACKLOG CLEARED FOLLOWING FDA WARNING LETTER that cites the firm for failing to make required reports for approved NDAs. Roberts Pharmaceutical said that it has eliminated the backlog of annual reports that were of concern to FDA. "Your firm has no system for maintaining required records and has failed to maintain required records or make required reports in several instances...regarding approved new drug applications," the Dec. 31 warning letter states.

The letter charges that annual reports were not filed from 1994-1997 for Topicycline (tetracycline), Dopar (levodopa), Duvoid (bethanechol), and Norethin 1/35E-21 (norethindrone and ethinyl estradiol).

The warning letter adds that Roberts extended the expiration date for Topicycline "to 48 months, an additional 24 months, without submitting and receiving approval of a supplement containing a new revised stability protocol" and did not submit field alert reports for out-of-specification stability results for two lots of the product. Roberts indicated that it has requested a meeting with the local division director regarding Topicycline.

Roberts also extended the expiration date for Furacin (nitrofurazone) 28 gram soluble dressing with a new revised stability protocol without FDA approval, the letter charges. In addition, Roberts "has failed to supplement Furacin Soluble Dressing NDA 05-795 to include PharmAssist Analytical Laboratory as a new contract laboratory."

The company's recordkeeping regarding moricizine is also addressed in the letter. "The content of the approved supplements for Ethmozine NDA 19-753 S-002, S-003, S-004 and S-005 could not be determined from the documentation available at your firm. It is your responsibility to assure you have received a complete copy of the applications, including supplements, or to request a copy from FDA's files."