Regulatory
-
Cipla Limited announced that the FDA has issued final approval of an ANDA for the company’s generic version of GSK’s Imitrex 20 mg sumatriptan nasal spray. Cipla’s sumatriptan nasal spray is an AB-rated generic. Imitrex… Read more . . .
-
Glenmark Pharmaceuticals announced that the Ministry of Health of the Russian Federation has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis, and the company expects to launch the… Read more . . .
-
According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune… Read more . . .
-
According to Janssen, the company’s Spravato esketamine nasal spray has been approved by the EC as an add-on to oral antidepressants for adult patients with major depressive disorder (MDD) “as acute short term treatment, for… Read more . . .
-
Lindal Group announced that the Chinese National Medical Product Administration’s (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal’s 20 mm male MDI metering valve as active following review.… Read more . . .
-
The European Commission has approved Chiesi’s Trimbow extrafine beclometasone / formoterol / glycopyrronium MDI for the treatment of asthma in patients who do not have adequate control with ICS/LABA and who have had at least… Read more . . .
-
According to AstraZeneca, China’s National Medical Products Administration (NMPA) has approved Symbicort Turbuhaler budesonide / formoterol as a reliever inhaler for the treatment of symptoms of mild asthma in patients age 12 and older. Symbicort Turbuhaler was… Read more . . .
-
According to Impel NeuroPharma, the FDA has accepted the company’s 5O5(b)(2) NDA for its INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of migraine headaches and has set a PDUFA goal date of September 6,… Read more . . .
-
Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA “resulted in clear guidance on the regulatory requirements” for development of the company’s RLS103 dry powder cannabidiol (CBD) for the treatment of panic… Read more . . .
-
Ovoca Bio said that its subsidiary IVIX has resubmitted a marketing application for the company’s BP-101 synthetic peptide nasal spray for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women to the Russian… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA