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出自识林

2016-07-12 Lachman CONSULTANTS

6月FDA共批准66件ANDA，其中51件完全批准（比GDUFA第4年到目前为止的月平均批准量略低）和15件暂时批准（TA）。6月接收量回升到79件，仅次于12月180件和3月114件的接收量，排名本财年第三。本财年到目前为止共502件完全批准，144件暂时批准，665件新接收ANDA。

2016财年已拥有9个月的数据，如果按目前平均值估计行业最感兴趣的两个指标，预计本财年完全批准量为669件，接收量为887件。

6月完全回应函（CRL）的发布数量为166封，仅次于4月的190封，成为本财年第二高的月份。根据目前月平均值估算本财年预计共发布1595封CRL，显著（26%）高于2015财年全年1180封的总量。如果2016财年月平均拒绝接收量接下来继续维持目前的月平均量大话，本财年似乎将比2015财年236件的总量超出21件。

随着2016财年第三季度的结束，OGD在批准量和CRL发布量方面似乎进展良好。让我们继续观察下个季度OGD在批准方面的表现。

Lachman CONSULTANTS - Bob Pollock先生
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June 2016 OGD Approval and Receipt Numbers Are In
By Bob Pollock | July 7, 2016

ANDA approval actions totaled 66 this month, with 51 full approvals (APs) (a little below the monthly average of 55.7 in year 4 of GDUFA so far) and 15 tentative approvals (TA). Receipts picked up to 79 for the month for the third highest month of this fiscal year (FY) (behind 180 in December and 114 in March). So far this FY, there are 502 full ANDA approvals, 144 TAs, and 665 new ANDA receipts.

With 9 months of data behind us for FY 2016, if we straight line average for the two metrics of most interest to industry, expect about 669 full approvals and 887 receipts for this FY.

The number of Complete Response Letters (CRLs) that were issued in June was 166. This represent the second highest output for a month, behind 190 in April. Monthly averages would show a FY total of about 1595 CRLs, with is up significantly (26%) over the FY 2015 complete year total of 1180. Refuse-to-File actions look like they will edge out last FY’s total of 236 by about 21 if FY 2016 monthly averages continue for the rest of the year.

As we come to the close of the third quarter of this FY, OGD appears to be on track to exceed its numbers for approvals and CRLs. Only industry can tell use what’s in store for approvals for the next quarter. Keep tuned!