Drug Approval | November 07, 2022
Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
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.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
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
Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir
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