Mumbai, Feb. 7 -- Shilpa Medicare has filed its Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch USP, ANDA for US market, marking its first-ever
transdermal patch submission to the U.S. Food and Drug Administration (USFDA).
This application submitted as an ANDA with USFDA is a generic version of the innovator product Neupro(R). Shilpa' s product is pharmaceutical and bioequivalent version of the reference product Neupro(R). Shilpa' s
Rotigotine patches are indicated for treatment of Restless Legs Syndrome and Parkinson's disease. The total addressable US market for Rotigotine is estimated at USD 112 million.
This Filling represents a significant milestone for the Company, being Shilpa Medicare's First transdermal patch dosage for...
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