Categories: US FDA Approval

MSN Group receives US FDA approval for Asenapine Sublingual Tablets

– It is indicated for the treatment of Schizophrenia & Bipolar disorder

Hyderabad, December 19, 2020: MSN Group (MSN) announced that it received final approval for its Abbreviated New Drug Application for Asenapine Sublingual Tablets, in 2.5 mg and 10 mg strengths, a generic for Saphris®, with the US Food and Drug Administration. These strengths will be launched immediately.  Additionally, the 5mg strength received tentative approval. The product will be launched by its marketing partner Breckenridge Pharmaceutical. MSN has over 100 ANDAs, 375 US Active Drug master files and are the World no 1 in US DMF Filings. MSN has nine active pharmaceutical ingredient and five finished dosage facilities in Hyderabad including one in the USA. Asenapine is indicated for the treatment of patients suffering from Schizophrenia & Bipolar disorder. 

As per industry sales data, Asenapine had annual sales of $239 million during the twelve months ending September 2020. 

Corporate Comm India (CCI Newswire)

The Pharma Times News Bureau

Recent Posts

World Diabetes Day Survey: Diabetologists and Endocrinologists demand for AI-Based Training and Upskilling in Diabetes Care

 A striking 90% of the 3000 Diabetologists and Endocrinologists surveyed, emphasised the importance of continuous…

3 days ago

Doctors warn diabetes patients about risk of smoking

People who smoke are also at much higher risk of developing diabetes compared to non-smokers…

5 days ago

CPHI & PMEC India Expo: Encouraging affordable solutions in India’s march towards a $130 Billion Pharma Market by 2030

17th edition of CPHI& PMEC India Expo to be held from 26th November-28thNovember 2024, at the India…

5 days ago

Sringeri Sharada Equitas Hospital Revolutionizing Cancer Care with the Launch of Low-cost, High Quality Radiation Therapy

The launch signifies Equitas’ redefined commitment to bring world-class cancer radiation therapy accessible to all.…

5 days ago