Drug Approval | June 12, 2022
Alembic receives USFDA tentative approval for Dasatinib tablets
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
The US business faced price erosion due to increased competition.
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
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