Drug Approval | December 21, 2021
U.S. FDA approves ANI’s rifabutin capsules, launch soon
The capsules are the generic version of the reference listed drug Mycobutin
The capsules are the generic version of the reference listed drug Mycobutin
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.
The tablets are indicated for the treatment of pulmonary arterial hypertension
Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
The company is moving towards complex and more differentiated products
Nelarabine is in a class of medications called antimetabolites
Subscribe To Our Newsletter & Stay Updated
