Cocktails of 2 mAbs based products are better equipped to deal with variants than single mAb based products which have a tendency of losing their efficacy with rapidly generating variants
This marks Glenmark's first synthetic decapeptide injectable approval
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.
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