The US Food and Drug Administration (FDA) has granted final approval to Breckenridge Pharmaceutical Inc, a subsidiary of Laboratorios Pen, SA, for its Abbreviated New Drug Application (ANDA) for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris), it was reported on Friday.

Breckenridge Pharmaceutical is planning to introduce these strengths immediately.

The FDA has granted tentative approval for the 5mg strength. The product was developed in partnership with MSN Laboratories Private Limited. The product is intended for the treatment of mental/mood disorders.