Company introduces bioequivalent version of Edarbi for hypertension treatment following U.S. FDA approval; product recorded annual U.S. sales of USD 53.5 million
Generic launch targets a US$19 million market in United States, strengthening Glenmark’s institutional and injectable product portfolio in North America
Dr Reddy’s has partnered with MSN Laboratories Private Limited on the product, with Dr Reddy’s holding exclusive US marketing rights while MSN leads development and manufacturing
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval
Company expands injectable portfolio with therapeutically equivalent version of Vimpat®, targeting a market valued at approximately $15.2 million annually
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
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