Natco Pharma Limited has received the final approval of its Abbreviated New Drug Application (ANDA) for lenalidomide capsules, 5mg, 10mg, 15mg, and 25mg strengths, from the US Food and Drug Administration (USFDA), and the tentative approval of the 2.5mg and 20mg strengths.
Natco, along with its marketing partner Arrow International Limited (a US affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name Revlimid.
Natco and Arrow shall launch the product on agreed-upon launch dates in the future.
The company also announced that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus tablets (generic for Zortress ), from the US Food and Drug Administration (USFDA).
BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.
Other drug approvals:
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