What caught attention in the press release (link) was mention that out of three applications, one is NDA (novel drug) approval:
Pre-Approval Inspections covering of three applications: NDA 016084, ANDA 217020, &
ANDA 217030.
Reading through the HSS ciruclar (available in public domain) carefully, this is an amendment to own existing NDA for 100 MG and 300 MG tablet for which approval was received prior to 1982 and listed as RLD drug. Over time, ALLOPURINOL has gathered competition with 25+ ANDA approval.
Mylan has NDA for Injectable route since 1996, however did not caught much competitor (except Gland and Hikma). My conjecture, Rx tablet are preferred by payers since facility cost may be involved with administrating injection through nurses/professionals.
Also, looked at the Orange book and was surprised (in mixed ways), all the filings under Casper are NDA only with RLD ‘Yes’. Most of them are bit legacy though (approved prior to 1982) with moderate competition only.
Thanks,
Tarun
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