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 company will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the Pandemic
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
PegIFN in COVID19 has several add-on advantages compared to other anti-viral agents
The receipt of this permission paves way for the launch of Osimertinib 40mg/80mg film coated tablets in India.
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