Page 2 of USFDA

This approval follows the acquisition of the Cimerli (ranibizumab-eqrn) business by Sandoz in the US earlier in 2024.

The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing…

Lymphir, Citius’ first approved treatment, is expected to launch within the next five months.

Ivosidenib Tablets, 250 mg have an estimated market size of US$ 114 million for twelve months ending March 2024, according…

Interestingly, Bkemv is the 53rd approved biosimilar in the U.S. The FDA has approved 13 of these as interchangeable biosimilars.

Theophylline Extended-Release Tablets, 300 mg and 450 mg had annual sales of USD 12.6 mn in the United States (IQVIA…

It had sales of approximately USD 19 million in the US for the 12 months ended January 2024, Gland Pharma…

The drug is used in combination with the Bacillus Calmette-Guérin (BCG) vaccine, which is mainly used against tuberculosis, but also…

Additionally, when lidocaine is applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of…

NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to…

Xolair is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis. Xolair received Priority Review and Breakthrough…