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.
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data
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
Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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