Overview of the Extension Period of an ANDA CRL
About fifty-one (51) pharmaceuticals will lose their patent protection in the United States in 2023, allowing generic medications to compete for some of the anticipated expired drugs. Monitoring these products’ expiration dates will make it easier to evaluate commercial prospects and improve entrance strategies. The importance of Abbreviated New Drug Application (ANDA) submissions should be understood by pharmaceutical organizations, and they should make sure that the documents they send include more information on the medicinal product for the appropriate Health Authority to review. Pharmaceutical companies wait for a response to the application after submitting it, unsure if it will be the big envelope containing an approval or the scrawny one containing a denial. Concerns about receiving a Complete Response Letter (CRL) from the US Food and Drug Administration exist among organizations (USFDA). A CRL outlines flaws, potential fixes, and options for continuing after the FDA denies the drug’s application for marketing.
The FDA issues a CRL when it determines that the information provided is insufficient to assess the suggested inspections and reviews for a specific medicine. Receiving a CRL causes drug approvals to be delayed, which has an effect on pharmaceutical companies and the suppliers they work with, leading to lost sales. An adverse response from stockholders and investors could lower a company’s valuation or restrict its capacity to obtain money.
How Might Applicants Retaliate Against a CRL?
A CRL recipient must reply within twelve (12) months of the CRL’s issuance. Unless the applicant has asked for an extension of time to resolve all the flaws listed in the CRL, the FDA may see this failure as a request to withdraw the ANDA if no response is provided. The Agency notifies the applicant in writing when it receives a request to withdraw the application.
Three (03) methods exist for reacting to a CRL:
1. Resubmission – A candidate may elect to resubmit the full ANDA application and correct each deviation listed by the FDA in the CRL. Resubmissions might be made by following the FDA’s advice or coming up with original ideas. The FDA will have two to six extra months to consider the application depending on the magnitude of the adjustments.
2. Withdrawal – The ANDA filing may be withdrawn by the applicant. Such a withdrawal is done without consequence and gives the applicant the opportunity to submit another ANDA.
3. Request an Opportunity for a Hearing – The applicant may ask to meet with the FDA to examine whether there are reasons to reject the application under Section 505(d) of the Rehabilitation Act (j). Although these hearings are available to the public, applicants should be made aware that granting the hearing does not obligate the FDA to reevaluate the application.
Period of Extension for an ANDA CRL
Whether or not an applicant wishes to keep requesting an ANDA approval is governed by FDA regulations. In order to correct the flaws noted in the CRL within one (01) year, the applicant must make sure the application contains all the documentation needed. It is possible to extend the deadline for fixing the deficiencies, but the applicant must file an amendment to the ANDA in order to do so. Later, before or on the CRL response date, the applicant should inform the FDA of the request for an extension.
For the purpose of submitting a request for an extension to reply to a CRL, the FDA advises taking care of the following matters:
• The applicant must outline their justifications for needing a CRL extension, which must include:
o A request for the first extension and an explanation of why the CRL’s response wasn’t handled within a year.
• A request for a further extension together with an explanation of why the applicant was unable to remedy the CRL inadequacies within the term allotted by the FDA in the earlier extension
o Details regarding further tasks the applicant must complete before replying to the CRL
Advances in the timeframe sought by the applicant to resolve the issues mentioned in the CRL. Authentication of the advancements made while working toward the completion of the work necessary to reply to the CRL.
Addressing the flaws listed by the FDA in the CRL takes months. Even though the FDA reviewer’s intentions may not have been the best, the applicants risk getting caught up in a game of regulatory whack-a-mole just as funding is running low and investors are losing faith. By timely providing the response package, a dependable partner like Freyr can help in assessing the FDA’s questions and helping to build an accurate plan. Visit to learn more about how Freyr can assist you in handling a CRL response.
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