Drug Approval | November 04, 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.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The product will be manufactured at Lupin's facility in Nagpur, India.
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The companies will leverage their respective proprietary technology platforms
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
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