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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-105/
- Published: 2019-08-25T12:00:00.000Z
- Updated: 2026-09-15T01:46:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5129693

**DEVICES**

FDA has cleared a **CorMatrix Cardiovascular** 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The device acts as a pouch to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body, according to the company.

**Nonin Medical** has received FDA clearance of its Nonin Model 3231 OEM/eHealth finger pulse oximeter, which plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. According to the company, the oximeter has features such as CorrectCheck technology, which provides feedback through a digital display if the patient’s finger is not placed correctly in the device and PureSAT Pulse Oximetery (SpO2) technology, which uses intelligent pulse-by-pulse filtering to provide precise oximetry measurements despite conditions such as motion, dark skin tones, low perfusion, rapid and SpO2 changes.

FDA has cleared a **Vital Connect** 510(k) for its HealthPatch MD biosensor for monitoring patients at home with chronic conditions, and for short-term monitoring after a patient is discharged from a hospital. It also allows caregivers to receive notifications on changes in patient conditions when physiological data falls outside selected parameters via a smartphone or other device, according to the company.

**HUMAN DRUGS**

**Fresenius Kabi** has received FDA approval for Kabiven and Perikabiven, parenteral nutrition products in a three-chamber bag, which according to the company, is the only container of its kind available in the U.S. The products contain amino acids with electrolytes, dextrose and lipids (Intralipid 20%). The company says the design of the three-chamber bag keeps the macronutrients separate and shelf-stable until the bag is activated and the contents mixed together for patient use.

FDA has approved an **InnoPharma, Inc.** ANDA for decitabine for injection, a generic version of Eisai Inc.’s Dacogen, indicated for treating patients with myelodysplastic syndromes (MDS). This includes patients previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

FDA has approved an **Iroko Pharmaceuticals** supplemental NDA for Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID) for managing osteoarthritis pain. The drug was originally approved in 2013 for treating mild to moderate acute pain in adults.

FDA has approved an expanded indication for **Pfizer and Protalix BioTherapeutics’** Elelyso (taliglucerase alfa) for injection for treating Type 1 Gaucher disease pediatric patients. The therapy is now indicated for long-term enzyme replacement therapy for both adult and pediatric patients. Approval was based on pediatric data from 14 patients in two clinical trials.

**Strides Arcolab Ltd.** has received FDA approval for Buspirone hydrochloride tablets USP, 5 mg, 10 mg, 15 mg and 30 mg, indicated for treating anxiety disorders and the short-term relief of the symptoms of anxiety.

**TWi Pharmaceuticals** has received final FDA approval for its ANDA for megestrol acetate 125mg/ml oral suspension, a generic equivalent of **Par Pharmaceutical’**s Megace ES, indicated for treating appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients.