Krystle Vermes

Cubicin treats complicated skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria.

Teva has just launched daptomycin for injection, a generic version of Cubicin, in the US market.

Virtus Pharmaceuticals Opco II recalls hyoscyamine sulfate tablets, sublingual, and orally disintegrating tablet forms, due to superpotent and subpotent test results.

Virtus Pharmaceuticals Opco II is recalling 7 batches of hyoscyamine sulfate 0.125 mg, which include tablet, sublingual, and orally disintegrating tablet forms, due to superpotent and subpotent test results.

Levonorgestrel-releasing intrauterine device can prevent pregnancy up to 3 years.

Allergan and Medicines360 have just launched a single-handed inserter for their Liletta levonorgestrel-releasing intrauterine device (IUD), which can prevent pregnancy up to 3 years.

The FDA has received several adverse event reports associated with Baxter's Vascu-Guard Peripheral Vascular Patch during carotid endarterectomy, including 3 potentially related patient deaths.

Novartis has introduced a new point-of-care diagnostic tool that allows for in-office diagnosis of uncontrolled allergic asthma mediated by immunoglobulin E (IgE) in conjunction with other clinical findings.

The FDA has extended the regulatory review period for Novo Nordisk's IDegLira, a potential once-daily fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza) for adults with type 2 diabetes.

The FDA is alerting women and their health care professionals about risks associated with the use of ovarian cancer screening tests.

The FDA is no longer allowing manufacturers to market OTC consumer antibacterial hand and body washes containing one or more of 19 active ingredients, including triclosan and triclocarban.

Greenstone LLC has just launched nitroglycerin sublingual tablets, an authorized generic version of Pfizer's Nitrostat.

The FDA has expanded the use of Amgen's blinatumomab (Blincyto) to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients.

The US Drug Enforcement Administration (DEA) is planning to place the active materials of the kratom plant under Schedule I of the Controlled Substances Act (CSA) in an effort to prevent a hazard to public safety.

The FDA has approved Novartis's etanercept-szzs (Erelzi), a biosimilar to Amgen's etanercept (Enbrel), for the treatment of several inflammatory diseases.

Sagent Pharmaceuticals is recalling one lot of injectable oxacillin because a single vial contained dark particulate matter identified as iron oxide.

Sanofi has submitted updated information to the FDA as part of a previously submitted New Drug Application (NDA) for its investigational once-daily, fixed-ratio combination of basal insulin glargine 100 units/mL (Lantus) and lixisenatide (Adlyxin) to treat type 2 diabetes in adults.

The FDA has granted Fast Track designation to Lilly and AstraZeneca's investigational treatment for Alzheimer's disease.

Roche recently launched an innovative blood glucose monitoring system designed to simplify everyday diabetes management with features like a spill-resistant test strip vial.

The drug received breakthrough therapy designation for this pending indication in July 2016.

The FDA is stopping all drugs produced by India-based Laxachem Organics from legally entering the United States after the company refused to allow FDA officials to inspect its facility.

Ton Shen Health is recalling its DHZC-2 tablets because they may be contaminated with elevated levels of lead.

The FDA has granted approval for Teva's cyclobenzaprine hydrochloride (Amrix) extended-release capsules to be administered by sprinkling the drug's contents onto a tablespoon of applesauce and swallowing immediately without chewing.

Arbor Pharmaceuticals is recalling 3 lots of acetylcysteine (Cetylev) effervescent tablets for oral solution (500 mg) because their blister packs may have inadequate seals.

Hospira is voluntarily recalling one lot of its 0.25% bupivacaine hydrochloride injection at the hospital and retail level.

Glenmark Pharmaceuticals' triamcinolone acetonide cream 0.1% has been granted FDA approval.

Drug to be evaluated combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.

Ribociclib seeking indication for use in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.

The FDA has granted breakthrough therapy designation to Novartis's ribociclib (LEE011).

The OTC and nutritional supplement products provider PharmaTech LLC is recalling all liquid products distributed between October 20, 2015, and July 15, 2016, due to potential contamination.