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news.Mylan has confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Amlodipine Besylate and Atorvastatin calcium tablets 2.5/10mg, 2.5/20mg, 2.5/40mg, 5/10mg, 5/20mg, 5/40mg, 5/80mg, 10/10mg, 10/20mg, 10/40 and 10/80mg.
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The product is the generic version of Caduet tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.
Mylan claims that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 2.5/10mg, 2.5/20mg, 2.5/40mg and 10/40mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Pfizer filed the lawsuit in the US District Court for the District of Delaware.
The company said that it has 142 ANDAs pending FDA approval. Forty of these pending ANDAs are potential first-to-file opportunities.