Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Stability testing takes time.

As of the last Q thy still hadn’t responded to the FDA regarding their concerns stated in the CRL and yet stated they “intend” to respond. I believe in CC mgmt clarified they prioritized the “avatar”
filing over Norco response.

As described by NH, the missing element in the Norco app was some kind of newly required stability/impurity test. Those kinds of tests take minimum 6 months to complete. I wouldn't be surprised if that same issue caused the generic OxyContin app to get kicked back on the front end (before it was accepted for review), nor would I be surprised if it has caused a delay in filing all subsequent ANDA's, including the Avatar. This was an industry-wide issue.






https://www.raps.org/news-and-articles/news-articles/2018/4/us-generic-drug-approvals-tick-upwards-in-march-an

US Generic Drug Approvals Tick Upward in March and April
Posted 18 April 2018 | By Zachary Brennan


2018 kicked off on a low note for generic drug approvals, but according to the latest activities report, the US Food and Drug Administration (FDA) in March began inching back to its fiscal year highs for approvals.

The decline in abbreviated new drug application (ANDA) approvals seen in January and February was attributed, at least partially, to the implementation of a new 1 January deadline for companies tracking elemental impurities. But those issues seem to have abated.

Robert Pollock, a senior advisor at Lachman Consultants, told Focus that he thinks the recent trend shows that the elemental impurities issue “appears to be less of a problem. I was a bit concerned the first 7 days in April due to very low numbers of approvals but April now appears to be in line with March approvals or even may even exceed March if the daily numbers for April continue.”

In addition to the growth in approvals in March and April, complete responses (CRs) sent in March also continued to decline, with less than half the number of CRs sent in March when compared to October 2017.

The updated figures come as FDA has released new considerations for applicants deciding when to submit elemental impurity data: One for ANDA applicants with a goal date in February and when the elemental impurity issue is the only outstanding deficiency, and the other for applicants with official goal dates in several months.

"In general, FDA recommends that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible," the agency said.