The FDA gave additional qualified infectious disease product status to Paratek Pharmaceuticals' antibiotic omadacycline.
BioCryst Pharmaceuticals was granted expanded approval by the FDA for use of Rapivab, or peramivir injection, to treat patients who are 2 years old or older with acute uncomplicated influenza who have been symptomatic for up to two days.
Amicus Therapeutics' ATB200/AT2221, indicated for the treatment of Pompe disease, received orphan drug designation from the FDA.
Merck and Pfizer's Bavencio, or avelumab, was approved by the European Commission as a treatment for patients with metastatic Merkel cell carcinoma. The drug is anticipated to be avaialable in the UK and Germany by October.
A nationwide recall was issued by Gear Isle for four dietary supplements because they contain undelared desmethyl carbodenafil, tadalafil and sildenafil, which can cause a life-threatening drop in blood pressure if they interact with prescription drugs. Affected in the recall were Papa Zen 3300, Rhino 7 Platinum 5000, Grande X 5800 and Fifty Shades 6000, which were shipped throughout the country via online sales.
Abiomed obtained premarket approval from the FDA for its percutaneous temporary ventricular support device, the Impella RP System, for use in right heart failure. The heart pump is indicated to deliver temporary right ventricular support for up to two weeks in patients with a body surface area of at least 1.5 m2 who experienced heart transplant, myocardial infarction, open-heart surgery or acute right heart failure or decompensation after left ventricular assist device implantation.
Elements Cranial SRS and Elements Spine SRS software applications, developed by Brainlab for facilitating patient-tailored radiosurgery treatment planning for the brain and spine, have been granted clearance by the FDA. Elements Cranial SRS allows for the creation of a radiosurgery plan in under 15 minutes, while Elements Spine SRS ensures direct delivery of high-radiation doses to the tumor, avoiding the spinal cord.
Abbott Healthcare received permission from India's National Pharmaceutical Pricing Authority to pull its Absorb and Absorb GT1b bioresorbable vascular scaffolds from the market. The company told the regulator that it was halting global manufacturing of the products because of low commercial sales after several countries issued safety alerts for the stents.
Grifols is scheduled to launch its Prolastin-C liquid next year after the FDA approved the formulation for use in patients with a rare genetic disorder.
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