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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has filed Abbreviated New Drug Application (ANDA) with the US FDA, seeking approval to market Risedronate Sodium Delayed-release Tablets (Atelvia), 35 mg to treat postmenopausal osteoporosis.
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Warner Chilcott (US) and Warner Chilcott Company had filed suit against Watson seeking to prevent Watson from commercializing its product.
The lawsuit which was filed under the provisions of the Hatch-Waxman Act resulted in a stay of final FDA approval of Watson’s ANDA.
Following the approval of ANDA for the drug, the company hopes to be entitled to 180 days of generic market exclusivity.