Drug Approval | November 03, 2022
Alembic receives USFDA approval for Mesalamine ER Capsules
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
The acquisition of these two brands expands Lupin's portfolio of inhalation products in the U.S.
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur.
The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.
There are certain foods can influence blood pressure, triglycerides, cholesterol levels and inflammation, all of which are risk factors for heart disease.
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