> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-61/
- Published: 2016-07-17T12:00:00.000Z
- Updated: 2026-09-14T21:14:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136211

**BIOLOGICS**

FDA has approved a **Pfizer** BLA supplement for Prevnar 13 (pneumococcal 13-valent conjugate vaccine \[diphtheria CRM197 protein\]) for an expanded age indication to include adults 18 through 49 years of age for active immunization for preventing pneumonia and invasive disease caused by 13 *Streptococcus pneumoniae* serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Previously, the indication was for adults 50 years and older.

**DEVICES**

FDA has approved an **Abbott Medical** **Optics** PMA for what the agency describes as the “first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.” Traditional monofocal IOLs have been limited to improving distance vision, an agency release says. “The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery,” it says.

**Abbott Vascular** has received approval from FDA for itsAbsorb GT1 bioresorbable vascular scaffold system, which releases the drug everolimus to limit the growth of scar tissue and is gradually absorbed by the body in about three years. It is the first fully absorbable stent to treat coronary artery disease. An FDA new release says that the device is manufactured from a biodegradable polymer called poly(L-lactide), similar to materials used in other types of absorbable medical devices such as sutures. The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed.

FDA has cleared a **Medifirst Solutions** 510(k) for its Time Machine TTML-8102000 Laser Thermal Therapeutic Device. The Infrared Laser at 810/830nm wavelength is indicated for temporary relief of minor muscle and joint pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

**Medtronic** has received FDA approval of aPMA supplement for the IN.PACT Admiral drug-coated balloon in longer (150 mm lengths), which will be available in four, five, and six mm diameters, for treating long lesions in patients with peripheral artery disease. “The long lesion (10-18 cm) sub-group outcomes from the IN.PACT SFA Trial at one year demonstrated superiority over balloon angioplasty,” the company says.

FDA has approved a **Novocure** PMA supplement for its second generation Optune system for treating adult patients with histologically-confirmed glioblastoma multiforme. The device features new smaller, lighter Tumor Treating Fields (TTFields) that are less than half the weight and half the size of the generator in the first Optune system, according to the company. Including its battery, the second generation Optune system weighs 2.7 pounds, compared to six pounds for the earlier model. “Novocure reduced the size and weight of Optune by utilizing novel digital signal generation technology,” the company says. “Additional improvements include: easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a ‘No-Stop Swap’ feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.”

FDA has approved the **Roche** cobas HPV test as the first test for human papilloma virus that can be used with cervical cells obtained for a Pap test and collected in SurePath preservative fluid. An agency statement says that the Roche test is the first to be approved for use with SurePath fluid, one of two approved liquid collection fluids commonly used for Pap tests. Prior to the approval, the statement says, some laboratories used cervical cell samples collected in SurePath fluid to run HPV tests, rather than collect an additional sample in a separate collection fluid that had been approved for use with those tests. The Roche cobas HPV test with Sure Path preservative fluid is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV to determine whether additional follow-up and diagnostic procedures are needed. FDA also approved the protocol for women age 21 and older who have already had an abnormal Pap test result to determine whether additional follow-up and diagnostic procedures are needed. The new test is also able to detect high-risk HPV genotypes 16 and 18 in the same population of women. FDA says that the new test is not approved as a first-line primary HPV screening test.

FDA has cleared a **Tandem Diabetes Care** 510(k) for the Tandem Device Updater, an Apple (Mac) and PC-compatible tool for remote updates to its Tandem insulin pump software. “The first use of the Tandem Device Updater will be for deployment of the latest t:slim Insulin Pump software to in-warranty t:slim Pumps purchased before 4/2015,” the company says. “Future software improvements and enhancements will be implemented through the Tandem Device Updater as they are cleared for commercial distribution.”

**HUMAN DRUGS**

**CSL Behring** has received FDA approval for the use of Berinert \[C1 Esterase Inhibitor (Human)\], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients. According to the company it is the only approved HAE treatment available to patients under 12 years of age.

FDA has approved **Galderma Laboratories’** Differin Gel 0.1% (adapalene), a once-daily topical gel for over-the-counter treatment of acne in people age 12 and older. An agency statement says Differin Gel is the first retinoid to be made available OTC for treating acne. FDA also says the gel contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin Gel was originally approved in 1996 as a prescription product for treating acne vulgaris in patients age 12 and older.

**Shire** has received FDA approval of anNDA for Xiidra (lifitegrast ophthalmic solution) for treating dry eye disease signs and symptoms. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, according to an agency release.