Amex accepts Milestone compliance plan
Milestone Scientific (Livingstone, New Jersey) said that the American Stock Exchange (Amex) had accepted the company's plan for regaining compliance with the exchange's stockholder equity continued listing requirement by the end of the plan period on June 30. Amex's acceptance letter states, “The plan makes a reasonable demonstration of [Milestone's] ability to regain compliance with the continued listing standards by the end of the plan period.“
Milestone had received notice from the exchange on Jan. 4 indicating that it was below the continued listing standards requiring stockholders' equity of $6 million, a level required as a result of Milestone's losses in its five most recent fiscal years.
The company submitted a plan for regaining compliance to the exchange on Jan. 14. As a result of the acceptance of the plan, Milestone will remain listed on the exchange, subject to periodic review to determine whether it is progressing consistent with the plan.
Alliance found by FDA to be in compliance
Alliance Medical (Phoenix), a reprocessor of single-use medical devices (SUDs), said that officials from the FDA have completed a comprehensive directed inspection of the company's Phoenix facility and found that Alliance is in full compliance with the Quality System Regulations. Alliance was not issued a form 483 Notice of Inspectional Observations by FDA.
The inspection was directed from the FDA's Office of Compliance, relating to the agency's review of all supplemental validation submissions on cleared 510(k) premarket notifications from reprocessing companies, as directed by the Medical Device User Fee and Modernization Act of 2002.
FDA denies generic Duragesic petitions
Noven Pharmaceuticals (Miami) reported that the FDA has denied pending citizen petitions intended to prevent or delay the approval of certain generic versions of Johnson & Johnson's (New Brunswick, New Jersey) Duragesic product, a fentanyl transdermal system. The company said the FDA denied petitions of Alza (Mountain View, California); Drs. Brookoff and Voth; the London & Mead law firm; and Dr. Steven Shafer.
Noven's fentanyl patch is a transdermal delivery system for the management of chronic pain. An abbreviated new drug application for Noven's patch is pending at the FDA. Marketing rights to the product in the U.S. and Canada have been licensed to Endo Pharmaceuticals (Clinton, New Jersey).