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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-34/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137796

**DEVICES**

FDA has cleared a **Bone Index Ltd.** 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a “Density Index,” a parameter which estimates bone mineral density at the hip as measured with a DXA x-ray machine, according to the company.

FDA has cleared an **OssDsign** 510(k) for the OssDsign Cranial PSI, a patient-specific medical implant intended for reconstruction of cranial defects (cranioplasty). Such procedures have traditionally been performed by neurosurgeons using a patient’s own bone or by using implants made from inert plastic or metal materials, such as PEEK or titanium. These techniques are known to have a high complication rate, according to the company, especially infections which may necessitate removal of the implant and further surgery.

**DRUGS**

FDA has approved a **Synergy Pharmaceuticals** NDA for Trulance (plecanatide) for treating adults with chronic idiopathic constipation (CIC). The company says Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

FDA has approved an **Allergan** NDA for RhoFade (oxymetazoline hydrochloride) cream for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29\. Data showed that the drug reduced persistent facial erythema associated with rosacea through 12 hours, according to the company.

FDA has approved a **Roxane Laboratories** ANDA for the first generic version of **Jazz Pharmaceuticals**’ Xyrem (sodium oxybate) oral solution for treating cataplexy and excessive daytime sleepiness in patients with narcolepsy. The approval requires Roxane to implement strict safety controls on prescribing and dispensing under a Risk Evaluation and Mitigation Strategy (REMS), an agency notice says.