Intellipharmaceutics International Inc. (IPCI)

[dtstx]

Things are picking up a bit. Notice the list below correlates with the companies you listed. The focus is/has been to get "first time generics" to market. As you review the monthly approvals on the FDA website concentrate on how fewer and fewer ANDA numbers below 201593 are becoming, indicating a higher percentage that one of our pending 4 are coming up for review. We are looking for roughly numbers between 201593 and 202161. If they concentrate just on those (which there are many that have been approved already) it would take about a yr at their current approval rate if none have been approved at all so we are a lot closer. It's not all that simple, as we know, but it gives you an idea, imo.



The Office of Generic Drugs (OGD) fully approved 47 ANDAs and Tentatively Approved 12 ANDAs for a total of 59 approval actions. While the number of full approvals falls below last month’s GDUFA high of 57, nevertheless, it represents an above average month for approvals for OGD.

The number of receipts in July was 40, and, thus, OGD managed to keep ahead of the receipts and will have the net effect of reduction of the backlog. At a net decrease of 19 ANDA/month the backlog that is hovering around 4000 will be around for a long time. Approval numbers really need pick up steam if OGD hopes to eliminate the backlog of pending applications.

With the new GDUFA FY 2016 fees just announced and an increase of 29% in the ANDA fee, we wonder if we will see a big push to get applications submitted before the new fees go into effect on October 1, 2015. Or will ANDA applicants hold off on submitting their ANDA even with the higher fees, in order to take advantage of the Cohort year 4 metrics that require OGD to review 75% of ANDA submitted in cohort year 4 in 15 months? It will be interesting to see if the differential in the higher fee or the 15% increased chance of being reviewed in a 15 month timeframe will drive industry decisions.

On a more positive note, I noticed that the FDA Monthly Approval site already lists 10 full ANDA approvals and 1 tentative approval with only 3 business days (August3-5) so far this month. This certainly represents a good start for this month.





Nine First Time Generic Approvals in July

By Bob Pollock | August 12, 2015 | FDA, Generics, Regulatory Affairs | ? 4 |






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.







http://www.lachmanconsultants.com/2015/08/office-of-generic-drugs-july-numbers-are-in/