Mylan Prevents FDA from Approving Other Norvasc Generics
by Aaron F. Barkoff
Orange Book Blog
Mylan Laboratories (MYL) announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007. Mylan launched its generic Norvasc last week and, with the exception of Pfizer's (PFE) authorized generic, currently has the only generic on the market.
Mylan was the first generic drug maker to file an ANDA for generic Norvasc, and is therefore entitled to a 180-day generic exclusivity period. However, FDA's policy for pre-MMA ANDAs (like Mylan's) is that the 180-day exclusivity period cannot extend beyond patent expiration. Pfizer's patent on Norvasc expired on Sunday, and therefore in the absence of the injunction the FDA could have approved other ANDAs for generic Norvasc.
According to the FDA website, the following generic drug companies have been granted tentative approval to market generic Norvasc, awaiting only resolution of exclusivity issues: Apotex, Dr. Reddy's, Gedeon Richter USA, Kali Labs, Matrix, Roxane, Teva, and Watson.
Mylan filed a Complaint and Emergency Application for a Temporary Restraining Order and/or Preliminary Injunction yesterday, and the district court ruled on it the same day. According to the district court's Order, the "FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007." The FDA is to notify the court of its decision no later than April 11 and is enjoined from taking final agency action "until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiff's application for a TRO."
Source: OrangeBookBlog.com
RELATED READING:
- Court Invalidates Pfizer's Norvasc Patent; Mylan's Generic to Launch Soon
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Orange Book Blog
Mylan Laboratories (MYL) announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007. Mylan launched its generic Norvasc last week and, with the exception of Pfizer's (PFE) authorized generic, currently has the only generic on the market.
Mylan was the first generic drug maker to file an ANDA for generic Norvasc, and is therefore entitled to a 180-day generic exclusivity period. However, FDA's policy for pre-MMA ANDAs (like Mylan's) is that the 180-day exclusivity period cannot extend beyond patent expiration. Pfizer's patent on Norvasc expired on Sunday, and therefore in the absence of the injunction the FDA could have approved other ANDAs for generic Norvasc.
According to the FDA website, the following generic drug companies have been granted tentative approval to market generic Norvasc, awaiting only resolution of exclusivity issues: Apotex, Dr. Reddy's, Gedeon Richter USA, Kali Labs, Matrix, Roxane, Teva, and Watson.
Mylan filed a Complaint and Emergency Application for a Temporary Restraining Order and/or Preliminary Injunction yesterday, and the district court ruled on it the same day. According to the district court's Order, the "FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007." The FDA is to notify the court of its decision no later than April 11 and is enjoined from taking final agency action "until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiff's application for a TRO."
Source: OrangeBookBlog.com
RELATED READING:
- Court Invalidates Pfizer's Norvasc Patent; Mylan's Generic to Launch Soon
_____________________
posted by Nico at
7:44 PM
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