Drug Approval | September 22, 2022
Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets
The ANDA was filed as 'First to File' submission on NCE-1 date.
The ANDA was filed as 'First to File' submission on NCE-1 date.
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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Veda Corporate Advisors was the exclusive financial advisor to SHPL and its shareholders.
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
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
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest
Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia
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