Regulatory

According to Kentucky-based AntiOp, the company has received Fast Track designation from the FDA for its intranasal naloxone for the reversal of opioid overdose. The company is co-developing the unit-dose nasal spray, its only product, with Reckitt Benckiser and has received approximately $4.5 million in grant funding from the National Institutes of Health and its … [Read more...] about AntiOp gets FDA Fast Track designation for its naloxone nasal spray

Teva has announced that the FDA has accepted its new drug application for an albuterol dry powder inhaler for the treatment of asthma in patients aged 12 and older. In October 2013, Teva indicated that it planned to submit a 505(b)(2) application for ProAir Spiromax by mid-2014. The company is referring to the breath activated multi-dose dry powder inhaler as an … [Read more...] about Teva submits NDA for albuterol dry powder inhaler

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD, GlaxoSmithKline and Theravance have announced. In April 2013, the companies announced that they had submitted a marketing application to the MHLW. The approval triggers a $10 million milestone payment from Theravance to … [Read more...] about Anoro Ellipta approved in Japan

Boehringer Ingelheim has announced that it has applied for approval to market its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD in the EU. Both of the individual drugs in the new combination inhaler are already available as Respimat products; tiotropium delivered by the SMI is marketed as Spiriva Respimat and olodaterol as Striverdi … [Read more...] about BI submits marketing application for tiotropium/olodaterol Respimat in Europe

GSK and Theravance have submitted a supplemental New Drug Application (sNDA) to the FDA for the Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma in patients 12 years old and older, the companies announced. The FDA approved Breo Ellipta 100/25mcg for the treatment of COPD in May 2013. The approval of Breo Ellipta for asthma required a … [Read more...] about GSK and Theravance file sNDA for Breo Ellipta for the treatment of asthma

The US FDA has announced the approval of MannKind Corporation's Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of the product on April 2, 2014. The product will have a boxed warning about bronchospasm … [Read more...] about FDA approves MannKind’s Afrezza inhaled insulin (updated)

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that children aged 2-8 should get a nasal spray flu vaccine if available instead of an injection. The CDC director must approve the recommendation before it becomes an official CDC policy. The FDA approved MedImmune's FluMist Quadrivalent … [Read more...] about CDC advisory committee recommends intranasal flu vaccine over injection for children

Strativa Pharmaceuticals has announced that it has received FDA approval for its disposable single-dose device version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies. The new product will be available in September 2014 and will replace the current multi-dose product. Strativa Senior VP Brand Sales … [Read more...] about FDA approval for single-dose Nascobal cyanocobalamin nasal spray