Barr Pharmaceuticals says that its subsidiary, Barr Laboratories, has received approval from the Therapeutic Products Directorate of Health Canada for its Abbreviated New Drug Submission for its Portia generic oral contraceptive as a generic equivalent of Wyeth Laboratories' Min-Ovral (levonorgestrel and ethinyl estradiol) tablets. This represents the first approval of a generic oral contraceptive for Canadian consumers.
Under the terms of an agreement with Apotex, Barr will manufacture the product and the former will market it in Canada. Apotex will record the Canadian sales of Portia and will pay Barr a royalty from these.
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