Regulatory

Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is… Read more . . .

Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company’s AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014.… Read more . . .

According to Sandoz, South Korea has approved 50 mcg/250 mcg and 50 mcg/500 mcg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The marketing authorization is the first for… Read more . . .

According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals’ NDA for Primatene HFA during a joint meeting… Read more . . .

Shortly after announcing that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According… Read more . . .

According to Teva, the company’s DuoResp Spiromax budesonide/formoterol fumarate inhalation powder has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The company has applied to market the product… Read more . . .

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22… Read more . . .

Sandoz has recently announced the approval of the AirFluSal Forspiro salmeterol/fluticasone DPI by Norway and Bulgaria, bringing the total number of European approvals to 7. The inhaler has also been approved in Denmark, Germany, Sweden,… Read more . . .