But now to business, if you have a PDUFA date between now and August 11 head’s up. Regular readers may recall that last week when writing about the decision at FDA to discontinue "approvable letters" in favor of the more general "complete response letter" (CRL), that the FDA chose the date of implementation of August 11. That prompted the statement from me: "Curious choice – rather than saying immediately, to say August 11. It makes you wonder if they aren’t going to come out with a few more. " Well, Give me the prize:
- Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment – As is a company’s prerogative, they revealed absolutely nothing about the factors that lead to the issuance of an approvable rather than approval letter. I won’t try reading the tea leaves on that one, perhaps this one was just in the hopper when the FDA decided to make its CRL announcement. But the other thing that was curious was that the treatment seems to have no name other than "the Head Lice Treatment" which I thought funny.
- TEVA to Acquire Barr Pharmaceuticals! – I don’t know, I’m not a business maven, but this stikes me as a WOW! – Teva announced this morning that it was acquiring Barr Pharmaceuticals for a whopping $7.46 billion. According to the release – "This acquisition will further enhance Teva’s leadership position in the U.S. and will significantly strengthen its position in key European and Central and Eastern European markets. On a pro forma basis, 2007 revenues of the combined company would have been approximately $11.9 billion. The combined company will have an unmatched global platform, operate directly in more than 60 countries and employ approximately 37,000 people worldwide. " Also according to the press release, Lehman Brothers acted as financial advisor to Teva in this transaction, and Willkie Farr & Gallagher LLP provided external legal counsel for Teva. Banc of America Securities LLC acted as financial advisor to Barr in this transaction, and Simpson Thacher & Bartlett LLP provided external legal counsel for Barr.
- Grab the Basil, Olive Oil and Make a Salad, Tomatoes are Back In! – Yesterday, MSNBC broke the news that the FDA was lifting its tomato ban before anything was released by press release from FDA – BUT, the FDA did finally issue a release that said "[a]fter a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. " This has the FDA in the soup (perhaps a nice gazpacho) with the tomato industry that lost untold sums of money and growers who either left product to rot on the vine or plowed it under in this time of a growing food shortage. That is going to make Congress see red.
That’s it for me this week. Have a good weekend everyone. Breathe easy!
Note: After initial publication, this posting was modified to include the tomator YouTube report.