Nine First Time Generic Approvals in July

 

Of the 47 ANDAs approved in July 2015, there were 9 first-time approved generic products. These represent the first time that the generic product was made available in the marketplace and demonstrates the Office of Generic Drug’s (OGD) commitment to getting first generics into the marketplace at the first available date.

The list of first-time ANDA approvals for July includes the following:

ANDA No Generic Drug Name Generic Manufacturer Brand Name AP Date
1 78-027 ALMOTRIPTAN MALATE TABLETS, 6.25 MG (BASE) 12.5 MG (BASE) TEVA PHARMACEUTICALS USA AXERT TABLETS 7/7/15
2 203431 TRAVOPROST OPTHALMIC SOLUTION USP (IONIC BUFFERED SOLUTION) 0.004% APOTEX INC. TRAVATAN Z 7/10/15
3 90-848 OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% BARR LABORATORIES, INC. PATADAY OPHTHALMIC SOLUTION 7/13/15
4 90-811 BIVALIRUDIN FOR INJECTION, 250 MG/VIAL (SINGLE USE) HOSPIRA, INC. ANGIOMAX INJECTION 7/14/15
5 90-816 BAVALIRUDIN FOR INJECTION, 250 MG/VIAL; PACKAGED IN ADD-VANTAGE VIA HOSPIRA, INC. ANGIOMAX INJECTION 7/14/15
6 200624 REPAGLINIDE AND METFORMIN HYDROCHLORIDE TABLETS, 1 MG/500 MG 2 MG/500 MG LUPIN LIMITED PRANDIMET TABLETS 7/15/15
7 200904 LINEZOLID INJECTION, 200 MG/100 ML 600 MG/300 ML SANDOZ, INC. ZYVOX INJECTION 7/16/15
8 205473 ETHACRYNATE SODIUM FOR INJECTION USP, 50 MG/VIAL PAR STERILE PRODUCTS LLC SODIUM EDECRIN 7/29/15
9 204152 OMEPRAZOLE MAGNESIUM DELAYED RELEASE TABLETS (OTC) 20.6 MG (20 MG BASE) PERRIGO R&D COMPANY PRILOSEC OTC DELAYED-RELEASE TABLETS, 20 MG 7/30/15

 

So far in FY 2015, OGD has approved 71 first-time generic ANDAs accounting for about 19% of the 373 ANDAs they approved through July 2015.  The 19% is down a bit from FY 2013 when about 25% of the ANDAs OGD approved were first-time generics (see previous post here).

OGD has indicated that first-time generics are a priority for review; however, many of the ANDA numbers associated with the July first-time approvals represent ANDAs submitted prior to 2009 when the numbering system changed to a consecutive system of number assignments for NDAs and ANDAs (the 200-000 series of numbers).  So the numbers list in the 90-000 series was submitted prior to that and the 78-000 series number in the list was actually submitted to FDA in 2005.  Now, it is possible that there might have been patent issues or exclusivity blocking approval, but, needless to say, all first approvals may not have been expedited due to certain circumstances beyond the scope of this bloggers specific knowledge.