Generics
Breckenridge Pharmaceutical's Abbreviated New Drug Application for Asenapine Sublingual Tablets in 5mg strength granted final FDA approval
9 March 2021 -

The United States Food and Drug Administration (FDA) has granted final approval to Breckenridge Pharmaceutical Inc, a subsidiary of Towa Pharmaceutical, for its Abbreviated New Drug Application (ANDA) for Asenapine Sublingual Tablets in 5mg strength (generic for Saphris), it was reported on Monday.

The company plans to introduce this strength immediately. It previously launched the product's 2.5mg and 10mg strengths and will now market all three strengths.

The product has been developed in partnership with MSN Laboratories Private Limited.

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