Drug Approval | July 24, 2024
Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
This product will be manufactured at Lupin’s Pithampur facility in India
Partners with Yifan Pharmaceutical to launch Synovian injection for osteoarthritis in China
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