Below is a summary of updates to the
<font> BioMedReports.com FDA Calendar </font> , which includes a database of 288 entries as of 8/5/09. 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, ANDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.
On 8/4/09, U.S. advisers backed FDA guidelines for testing less costly generic versions of the antibiotic Vancocin (vancomycin) despite objections by the brand product manufacturer ViroPharma (NASDAQ:VPHM). VPHM argued that the Agency's proposed criteria for generic rivals were not rigorous enough to prove the copies would work as well as the brand-name product. But panel members said they felt confident in the FDA's suggested test methods for generics, and the committee voted 16-0 to back the FDA plan for generic versions of Vancocin.
The Advisory Committee was asked if the proposed FDA Office of Generic Drugs (OGD) guidelines and the use of in vitro (outside of the human body – i.e. requiring no clinical trials to prove) dissolution methods are sufficient for establishing bioequivalence for generic vancomycin oral capsules. The Advisory Committee voted unanimously in favor of the proposed OGD recommendation to demonstrate bioequivalence through equivalent dissolution in media of pH 1.2, 4.5 and 6.8 for potential vancomycin HCl capsule generic products that: (1) contain the same active and inactive ingredients in the same amounts as Vancocin capsules; (2) meet currently accepted standards for assay, potency, purity, and stability; and (3) are manufactured according to cGMP.
On 8/4/09, Electro-Optical Sciences (NASDAQ:MELA) announced that the FDA formally accepted for filing the company's Pre-Market Approval (PMA) submission seeking marketing clearance for MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The filing date for regulatory purposes is 6/9/09, which is the date the FDA received the Company’s submission. The FDA also confirmed that the PMA application will receive expedited review and processing with an expected review period of six months.
Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May. The Company's final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians.
On 8/4/09, Wyeth (NYSE:WYE) and Progenics Pharma (NASDAQ:PGNX) announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010.
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