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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-101/
- Published: 2019-07-28T12:00:00.000Z
- Updated: 2026-09-15T01:40:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5133379

**DEVICES**

FDA has approved a **Cook Medical** PMA for its lower-profile Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular treatment of patients with isolated lesions within the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair. The device features a 16-20 French delivery system that is intended to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy, the company says. Its introduction system also features an “ergonomic design that requires fewer procedural steps than previous designs to deploy the device without sacrificing the precision and control of the Zenith platform,” it says.

FDA has approved a **Medtronic** PMA for its Evera MRI SureScan ICD System, an implantable cardioverter defibrillator for use with magnetic resonance imaging (MRI) scans. The device’s approval covers MRI scans on any part of the body without positioning restrictions, according to the company. It includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional, it says.

**HUMAN DRUGS**

FDA has approved an **Allergan** and **Gedeon Richter** NDA for Vraylar (cariprazine) capsules, an atypical antipsychotic for acute treatment of manic or mixed episodes associated with bipolar I disorder and for treating schizophrenia in adults.

**Impax Laboratories** has received FDA approval of its generic of Mestinon Timespan tablets (pyridostigmine bromide extended release), 180 mg, indicated for treating myasthenia gravis.

FDA has approved **Jubilant Life Sciences’** ANDA for zolmitriptan orally disintegrating tablets in strengths of 2.5 mg and 5 mg, a generic version of **AstraZeneca’**s Zomig-ZMT tablets, which is used for acute treatment of migraine headaches in adults.

**Octapharma** has received FDA approval of anNDA for Nuwiq (antihemophilic factor-recombinant), indicated for treating adults and children living with hemophilia A. The approval covers on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce bleeding episode frequency; and perioperative bleeding management. “Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with Hemophilia A, congenital FVIII deficiency,” the company says.