Alembic Pharmaceuticals announces USFDA Tentative Approval for Bosutinib Tablets
Mumbai, 1st July 2024: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism).
Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia. Refer label for a detailed indication.
Bosutinib Tablets have an estimated market size of US$ 275 million for twelve months ending March 2024 according to IQVIA.
Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USFDA.
More Stories
TheHealthSite.com reveals 5 indoor exercises to avoid depression and improve mental health
Several indoor exercises can help alleviate the symptoms of depression and maintain good mental health. As recommended by TheHealthSite.com, yoga...
Regency Healthcare performs one of its kind robotic-assisted surgery to save a CRPF officer from a complex recurring hernia
Kanpur, 02 July 2024: Regency Healthcare, a leading multi-speciality hospital in Kanpur, performed a Robotic Abdominal Wall Reconstruction surgery to...
Sunny Hinduja Joins Counsel India to Champion Mental Wellness Among Youth
Noida, July 02, 2024: Renowned actor Sunny Hinduja celebrated for his versatile and compelling performances in the Hindi film and...
Happiest Health Appoints Dr Sreenivasan Narayana as President & CEO of Healthcare Services Division
Bengaluru, July 2nd, 2024: Happiest Health announced the appointment of Dr Sreenivasan Narayana as President & Chief Executive Officer of...
Manasthali helps to regain confidence, self-love of a young boy after surviving 70% of burn injury
New Delhi, 02nd July 2024: Burn injuries can significantly affect a person's confidence, as they often leave visible scars and...
Medica Superspecialty Hospital & Rotary launch paediatric & cervical Cancer initiatives on National Doctors’ Day
[caption id="attachment_115281" align="aligncenter" width="786"] On the occasion of National Doctors' Day, Dr. Sayan Das, Senior Consultant & Head (Radiation Oncology),...