Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 273 entries as of 7/22/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 7/22/09, Schering-Plough (NYSE: ) announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate was filed and accepted for review by the FDA. The NDA is seeking marketing approval from the FDA for the maintenance treatment of asthma in patients 12 years of age and older. This new product combines the active ingredients of already-approved and marketed single-agent products which include an inhaled corticosteroid (Asmanex -mometasone furoate inhalation powder) and a long-acting beta2-agonist (Foradil - formoterol fumarate inhalation powder), administered via a single metered-dose inhaler. SGP has exclusive worldwide rights for the development and commercialization of the mometasone furoate and formoterol furmarate fixed-dose combination and is in the process of being acquired by Merck (NYSE: ).
On 7/22/09, Hemispherx Biopharma (AMEX: ) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency.
