Drug Approval | March 23, 2024
Zydus receives tentative approval from USFDA for Letermovir Tablets
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
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