Alembic Pharma Gets USFDA Nod For Bipolar Disorder Treatment
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Alembic Pharmaceuticals on Dec 11th said that it has received final approval from the US health regulator for Asenapine Sublingual tablets, indicated for treatment of bipolar disorder. The approved product is therapeutically equivalent to the reference listed drug product Saphris Sublingual tablets of Allergan Sales, LLC.

In a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets in the strengths of 5 mg and 10 mg.

Alembic had previously received tentative approval for this ANDA. Alembic Pharma said it was one of the first applicants to submit a substantially complete ANDA and hence is eligible for 180 days of shared exclusivity. Alembic Pharma has a cumulative total of 137 ANDA approvals from USFDA.

Source:
https://health.economictimes.indiatimes.com/news/pharma/alembic-pharma-gets-usfda-nod-for-bipolar-disorder-treatment-drug/79675440
1 share
Like
Comment
Share