USFDA

U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

TESARO, Inc., an oncology-focused biopharmaceutical company, announced that VARUBI™ (rolapitant), an NK-1 receptor antagonist, is now available in the United States. The U.S. Food and Drug Administration (FDA) approved VARUBI on Sept. 1, 2015, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Meridian Bioscience, Inc. announced it has received clearance from the U.S. Food and Drug Administration (FDA) for new claims for its illumigene® Pertussis molecular amplification test. The upgraded test reduces the effect of inhibitors in biologic samples and significantly expands Meridian’s customer base by including specimens collected by ESwab™ (Copan Diagnostics, Inc.).
ESwab is a multipurpose universal transport system that a significant portion of laboratories in the United States currently use to streamline workflows and eliminate costs associated with stocking multiple swab types.

Zydus Cadila has received US health regulator's nod to initiate phase II clinical trials of Sarolitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits.

Sandoz, a Novartis company and the global leader in biosimilars, announced  that the 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 Neulasta® (pegfilgrastim) - a recombinant human granulocyte colony-stimulating factor (G-CSF).

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura. In adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

Collegium Pharmaceutical, Inc.  announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

[adsense:336x280:8701650588]

Protalix BioTherapeutics, Inc.  announced that it recently held an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company's proposed BLA plan for PRX-102 for the treatment of Fabry disease. Official FDA meeting minutes indicate the FDA's acceptance of the Company's path forward for a phase III clinical trial to support a full BLA approval.

Mallinckrodt plc, a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR® Plus MRI device for delivery of INOMAX® (nitric oxide) for inhalation during MRI procedures.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that its state-of-the-art recombinant biologic manufacturing facility in Singapore received U.S. Food and Drug Administration (FDA) approval to produce ADVATE [Antihemophilic Factor (Recombinant)] bulk drug substance (BDS). The site received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE.