Policy | May 24, 2021
NATCO Pharma receives USFDA approval for Lenalidomide capsules
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
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
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.
ranules now has a total of 38 ANDA approvals from US FDA.
The company will review FDA's response and decide on appropriate next steps soon.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
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