Regulatory

Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson's disease patients has been changed from October 5, 2018 to January 5, 2019. The company said that the FDA extended the review period because Acorda's submission in response to a request by the … [Read more...] about NDA for Inbrija inhaled levodopa gets new PDUFA date

The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva's ProAir RespiClick, which was approved for the treatment of asthma in adults in 2015 and for pediatric use in 2016. The draft … [Read more...] about FDA issues new draft guidance for albuterol sulfate DPIs

Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which Biohaven licensed from Bristol-Myers Squibb, is delivered using Aptar Pharma's unit dose system. … [Read more...] about Biohaven submits IND for intranasal CGRP receptor antagonist for migraine

Glenmark Pharmaceuticals announced that it has received marketing approval from German authorities for its generic version of Seretide Accuhaler and said that the product will be marketed in Germany as "Salflutin." The company acquired development and marketing rights to the fluticasone/salmeterol DPI from Celon for 15 countries, including the UK, Germany, … [Read more...] about Glenmark’s generic version of Seretide Accuhaler approved in Germany

Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to the EMA for esketamine nasal spray for the same indication later this year. In May 2018, Janssen published positive results from a Phase 3 … [Read more...] about Janssen submits NDA for esketamine nasal spray

insys Therapeutics' epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray showed that its bioavailability was similar to that of intramuscular formulations. The company has several OINDPs in development, including a dronabinol … [Read more...] about Insys gets Fast Track designation for its epinephrine nasal spray

Medical Developments International (MVP), which announced in July 2018 that it was expecting a clinical hold letter from the FDA regarding its US clinical program for its Penthrox methoxyflurane inhaler, said that it has now received the letter from the FDA and believes that the company can satisfy the FDA's requirements. According to MVP, the FDA is requiring the … [Read more...] about MVP says it believes it can meet FDA requirements for Penthrox IND

The FDA has granted fast track designation to NeuroproteXeon (NPXe) and Mallinckrodt’s inhaled xenon gas for the treatment of post-cardiac arrest syndrome (PCAS), the companies said. A Phase 3 trial of inhaled xenon for that indication is expected to get underway in the next few months. NPXe’s Xenex inhaled xenon has received orphan drug designation from the FDA … [Read more...] about Inhaled xenon gas for PCAS gets fast track designation

Evoke Pharma has announced that the FDA has accepted the company's 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, which Evoke submitted in June 2018. The PDUFA date has been set for April 1, 2019. In a separate letter, the agency also informed Evoke that it had conditionally … [Read more...] about Evoke’s NDA for Gimoti accepted for review by the FDA

According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March 31, 2019 for both applications. The Tudorza sNDA requests to add COPD exacerbation reductions and cardiovascular safety data to the prescribing … [Read more...] about FDA accepts NDA for Duaklir, sNDA for Tudorza