USFDA

Stryker Corporation, one of the world's leading medical technology companies instruments division of interventional spine business unit has received clearance from the US Food and Drug Administration (FDA) to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures.

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market. The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg.

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis.1 The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.

The US Food and Drug Administration approved Alkermes Inc's Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia.  Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

Impax Laboratories, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved its generic version of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg. The company is preparing for commercialisation of this product through Impax's generic division.

Allergan plc,, a leading global pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

Sandoz, a Novartis company and the global leader in biosimilars, announced that US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel (etanercept) - a tumour necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.

The U.S. Food and Drug Administration allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.