Shire receives paragraph IV notice letter from Corepharma

By Elaine Rigoli

Tampa, Fla., April 6 - Shire plc has received a paragraph IV notice letter from Corepharma LLC advising of the filing of an abbreviated New Drug Application for its carbamazepine extended-release products, generic versions of Shire's Carbatrol.

The notice letter is directed to 100 mg, 200 mg and 300 mg strength products.

Shire said it is reviewing the details of the notice letter.

Shire previously announced that it received a notice letter from Nostrum Pharmaceuticals, Inc. regarding its aNDA for a 300 mg-strength generic Carbatrol product.

Shire has filed a lawsuit against Nostrum regarding this notice letter and the litigation is pending, the release said.

Based in Chineham, England, Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies.

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