Breckenridge Pharmaceutical announced the U.S. Food and Drug Administration (FDA)has granted final approval of its Abbreviated New Drug Application (ANDA) for Asenapine Sublingual Tablets in 5mg strength (generic for Saphris®).
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Breckenridge plans to launch this strength immediately. The Company previously launched the product's 2.5mg and 10mg strengths and will now market all three strengths. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $233 million during the twelve months ending December 2020.