This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics. A total of 28 applications were approved by FDA during these three months.
The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is the largest component under the U.S. President’s Global Health Initiative. Under the PEPFAR initiative, the government of the United States helps people suffering from HIV/AIDS around the world. All the FDA activities under this relief plan are conducted under FDA’s Office of International Program’s Asia and Africa Office. This plan provides an expedited review process for antiretroviral (ARV) therapies. Lamivudine; Tenofovir Disoproxil Fumarate, Dolutegravir; Emtricitabine; Tenofovir Alafenamide and Efavirenz have been approved under PEPFAR for the treatment of HIV infection between January to March 2018.
Out of 28 new drug approvals, 13 approvals have been granted on priority review process by FDA. FDA’s Center for Drug Evaluation and Research (CDER) Manual of Policies and Procedures (MAPP) 6020.3 Rev. 2 defines the Priority and Standard review designation policy. According to this policy, the review designation is assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies. Drugs that do not meet the priority review criteria fall under Standard review.
The Manual of Policies and Procedures (MAPP) 5018.2 of CDER, describes different classification codes to an NDA according to the characteristics of the product and their relationships to other approved or marketed products in the United States. The NDA classification codes are Type 1: New Molecular Entity, Type 2: New Active Ingredient , Type 3: New Dosage Form, Type 4: New Combination, Type 5: New Formulation or Other Differences (e.g., new indication, new applicant, new manufacturer), Type 6: New Indication or Claim, Same Applicant, Type 7: Previously Marketed But Without an Approved NDA, Type 8: Rx to OTC, Type 9: New Indication or Claim, Drug Not to be Marketed Under Type 9 NDA After Approval, Type 10: New Indication or Claim, Drug to be Marketed Under Type 10 NDA After Approval. There are applications which fall under more than one type of NDA submissions. These codes include, Type 1 & 4, Type 2 & 3, Type 2 & 4 and Type 3 & 4. Biktarvy® was submitted under Type 1& 4 submission classification.
Out of 28 approvals, FDA granted tentative approval to seven applications. These include Cabazitaxel Injection; Lamivudine, Tenofovir, Disoproxil Fumarate Tablet; Dolutegravir, Emtricitabine, Tenofovir, Alafenamide Tablet; Lusduna Injection; Efavirenz Tablet; Sincalide Injection and Pemetrexed Injection. According to 21CFR 314.105, FDA will grant tentative approval to an application, NDA or 505(b)(2), if the application meets the requirements of FD&C act but there is a period of exclusivity, orphan or pediatric exclusivity for the listed drug.