Opinion ID: 768768
Heading Depth: 2
Heading Rank: 3

Heading: Elan's ANDA

Text: 9 Elan submitted an ANDA to the FDA on April 30, 1997, seeking approval for a product that is bioequivalent to Bayer's ADALAT CC product. Elan's ANDA covers a once-daily formulation of nifedipine--an extended release tablet dosage form containing 30 mg of nifedipine. With its ANDA, Elan filed a Certificate of Quality and Analysis (COA). The COA related to an analysis performed by Freiberger NE-Metall GmbH (FNM), an independent laboratory, on April 17, 1996 with respect to the micronized--finely ground--nifedipine provided to Elan by its nifedipine supplier, Arzneimittelwerk Dresden GmbH (AWD). According to the COA, the measured SSA of the micronized AWD nifedipine crystals was 6.15 m2/g. The tablets made from these micronized nifedipine crystals and tested for the ANDA process are referred to by the parties as the biobatch. Elan also filed with its ANDA a Paragraph IV certification, in which it stated that its nifedipine composition did not infringe the '446 patent or Bayer's United States Patent No. 4,892,741 (the '741 patent). On July 8, 1997, Elan sent Bayer, as required by 21 U.S.C. § 505(j)(2)(B)(ii), notice of its ANDA and its Paragraph IV certification, noting that the SSA of its nifedipine was outside any of the '446 patent's claimed SSA ranges. 10 On March 18, 1998, Elan amended its ANDA by stating that it had revised the specification for its composition so that the composition only covered nifedipine crystals of a SSA of 5 m2/g or greater. On October 23, 1998, in response to the FDA's request for Elan to define its method of testing and its testing commitment to ensure the nifedipine's SSA, Elan stated that it intended to measure the SSA of its nifedipine no more than five business days before tablet manufacture and that it would discard any nifedipine having a SSA of less than 5 m2/g.