According to Trimel Pharmaceuticals, the FDA has approved its Natesto nasal testosterone for men with low levels of endogenous testosterone. Trimel submitted an NDA for the product, then called CompleoTRT, in April 2013. Trimel President and CEO Tom Rossi said, “The FDA approval for Natesto is a major achievement for our company, as it validates our clinical … [Read more...] about FDA approves Trimel’s Natesto testosterone nasal gel
Regulatory
FDA approves QVAR HFA with dose counter
The FDA has approved Teva's QVAR beclomethasone HFA metered dose inhaler with a dose counter for the treatment of asthma, and the company plans to launch the product later in 2014, Teva said. Teva Global Respiratory Research and Development Senior VP Tushar Shah commented, “Bringing QVAR with a dose counter to market reaffirms Teva’s commitment to addressing unmet … [Read more...] about FDA approves QVAR HFA with dose counter
GSK files application for UMEC monotherapy in Japan
GlaxoSmithKline has submitted an NDA for its umeclidinium (UMEC) Ellipta DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare, the company announced. The product was approved under the name Incruse Ellipta in the US, in Canada, and in Europe in April 2014. According to GSK, "Regulatory filings in other countries will take place … [Read more...] about GSK files application for UMEC monotherapy in Japan
Aradigm’s Pulmaquin gets QIDP status
Aradigm has announced that the FDA has designated its Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis patients as a Qualified Infectious Disease Product (QIDP). QIDP status makes the product eligible for the FDA's Fast Track expedited review program. Aradigm CEO Igor Gonda said, "We are very … [Read more...] about Aradigm’s Pulmaquin gets QIDP status
Skyepharma provides updates on Flutiform
As part of an interim management statement, Skyepharma has said that the launch of its Flutiform fluticasone/formoterol MDI in Spain could take place by the end of 2014, triggering a milestone payment of €2.0 million. The company also noted that it has received a €3.0 million milestone payment for the launch of the product in France in the first quarter of 2014. In … [Read more...] about Skyepharma provides updates on Flutiform
FDA approves Apotex’s generic budesonide nasal spray
Apotex says that it launched a generic budesonide nasal spray in the US on May 13, 2014 following the previous day's approval of the product by the FDA. The new product, with a strength of 32 mcg/spray, is a generic equivalent for AstraZeneca's Rhinocort Aqua. Apotex's suggested average wholesale price is $160.53, which appears to be similar to the retail price of … [Read more...] about FDA approves Apotex’s generic budesonide nasal spray
FDA accepts Teva’s supplemental application for pediatric QNASL
Teva has announced the FDA's acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL for the treatment of seasonal and perennial allergic rhinitis in patients 12 and older in March 2012. Teva Senior VP Global Respiratory … [Read more...] about FDA accepts Teva’s supplemental application for pediatric QNASL
FDA approves Perrigo’s azelastine nasal spray
Perrigo has announced that it has begun shipping its generic version of Astepro azelastine nasal spray after the ANDA it submitted in partnership with Impax Laboratories received final approval from the FDA. In January 2012, after the two companies filed the ANDA, Astepro maker Meda Pharmaceuticals filed suit for patent infringement in US District Court. According to … [Read more...] about FDA approves Perrigo’s azelastine nasal spray
Anoro Ellipta approved in Europe
GlaxoSmithKline and Theravance have announced that they have received marketing authorization for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD in Europe. The EMA's Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion regarding Anoro in February 2014. The approval triggers a $15 million milestone payment from … [Read more...] about Anoro Ellipta approved in Europe
FDA approves Propeller Health’s latest inhaler tracking system
Propeller Health (formerly known as Asthmapolis) has announced that the latest version of its inhaler tracking system has received 510(k) clearance from the FDA. The system includes a sensor that snaps onto an MDI and mobile apps that monitor and analyze inhaler use. According to Propeller, the newly approved system also predicts asthma and COPD exacerbations and … [Read more...] about FDA approves Propeller Health’s latest inhaler tracking system