Drug Approval | 04 November 2022
Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
The CRL did not identify any outstanding scientific issues with the product.
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
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
The company increases its efficiency and is able to face the growing demand for its services.
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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