Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: FDA Announcements
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Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt. For more: AP; Reuters; WSJ. Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis. Sanofi already owns 25% of the company. Meanwhile, the WSJ Health Blog recently reported that the CEOs…
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For the second time in as many weeks, FDA has asked interested parties to submit comments regarding 180-day generic drug exclusivity issues. On September 26, as FDA Law Blog reported, FDA requested comments on exclusivity for generic Precose (acarbose) tablets; last week, FDA asked for comments on exclusivity for generic Altace (ramipril) capsules. Two letters…
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The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing. According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing. Biosimilars legislation is "off the table" for now. The FDA…
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Last week, the U.S. District Court for the District of Columbia denied Mylan’s emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer’s Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer’s patent, Mylan and Apotex had the only approved ANDAs for generic Norvasc. Bloomberg reported…
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According to SCOTUSblog, Pfizer filed an emergency plea with the Supreme Court yesterday, asking the Court to delay the effect of the Federal Circuit’s rulings against Pfizer in the Norvasc case. Separately, Pfizer filed a petition for certiorari and a motion for expedited review of the Federal Circuit’s March 22 decision invalidating three claims of…
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Dr. Steven Galson, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, recently announced a new "First Generics" policy for review of ANDAs. Under the agency’s current "First-In, First-Reviewed" policy, CDER reviews ANDAs in the order in which they are received. Under the new policy, FDA will make exceptions to the…
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The FDA announced last Friday that it recently began using the Division File System (DFS) for reviewing and archiving Abbreviated New Drug Applications electronically. According to the FDA’s press release: This system will now allow electronic archiving of ANDA documents for better tracking and search capabilities. It will also enable reviews to become part of…
Orange Book Blog 