The FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 "who require treatment with both components," the company said. Dymista was approved for adults and for children 12 and older in 2012. Meda submitted data from two pediatric trials to support the … [Read more...] about Meda’s Dymista gets FDA approval for children aged 6-11
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Aegis Therapeutics gets patent for intranasal formulations
Aegis Therapeutics has announced that the US Patent and Trademark Office has awarded the company US Patent No. 8,927,497, which covers a method "for non-invasive delivery of anti-seizure drugs via a simple metered nasal spray" based on the company's Intravail transmucosal absorption enhancement technology. The patent, titled "Absorption enhancers for intranasal … [Read more...] about Aegis Therapeutics gets patent for intranasal formulations
Elder Pharma introduces intranasal products
Mumbai-based Elder Pharmaceuticals has announced the introduction of a line of over-the-counter "inhalers for nasal congestion." The intranasal products will be sold under the Solo brand, a range of products that also includes a pain balm, cough drops, and throat lozenges. The company said that it will target rural markets with the Solo brand. Elder Pharmaceuticals … [Read more...] about Elder Pharma introduces intranasal products
Dance Biopharm completes $9.5 million financing
Dance Biopharm has announced the completion of a $9.5 million private placement that will fund clinical trials of its Dance 501 inhaled insulin. The Phase 2 program for Dance 501 is complete, according to the company's web site, and Phase 3 trials are being planned. Earlier this month, Dance announced that it had hired Tyler Martin in the newly created position of … [Read more...] about Dance Biopharm completes $9.5 million financing
Lupin begins selling valved holding chamber licensed from InspiRX in the US
Lupin Pharmaceuticals has announced the launch of the InspiraChamber valved holding chamber after it acquired exclusive US rights to the device from InspiRX. The InspiraChamber is being sold as part of a package with pediatric face masks, including the SootherMask, which has a slot for a pacifier. InspiRX CEO Michael Amato commented, "The agreement enables the … [Read more...] about Lupin begins selling valved holding chamber licensed from InspiRX in the US
AstraZeneca gets temporary injunction to stop Actavis sales of generic version of Pulmicort Respules
The United States Court of Appeals for the Federal Circuit has granted AstraZeneca's request for a temporary injunction stopping Actavis from further sales of its budesonide inhalation suspension, according to Actavis. AstraZeneca has appealed the decision earlier this month that ruled US Patent No. 7,524,834 was invalid, after which Actavis announced the launch of … [Read more...] about AstraZeneca gets temporary injunction to stop Actavis sales of generic version of Pulmicort Respules
Adapt Pharma gets Fast Track designation for intranasal naloxone
The FDA has granted Adapt Pharma Fast Track designation for its intranasal naloxone for the treatment of opioid overdose, the company said. Adapt Pharma licensed the product from Lightlake Therapeutics in December 2014. In the same month, Lightlake began a new trial of the drug for the opiod overdose reversal indication. Funding for the trial has been provided by the … [Read more...] about Adapt Pharma gets Fast Track designation for intranasal naloxone
Celon Pharma and Lupin team up to develop fluticasone/salmeterol DPI
Lupin Limited and Polish biopharmaceutical company Celon Pharma have announced that they will co-develop a generic version of GSK's Advair Diskus. Celon, which currently markets a fluticasone/salmeterol DPI called Salmex in Poland, will supply the the product to Lupin, and Lupin will commercialize the product in North America and "other key markets." Lupin CEO … [Read more...] about Celon Pharma and Lupin team up to develop fluticasone/salmeterol DPI
Actavis launches generic version of Pulmicort Respules
Actavis has announced that after the United States District Court for the District of New Jersey denied AstraZeneca's request for a permanent injunction and ruled that US Patent No. 7,524,834 is invalid, Actavis launched its generic version of AstraZeneca's Pulmicort Respules budesonide inhalation suspension in 0.25 and 0.5 mg vials. The FDA approved Actavis's ANDA … [Read more...] about Actavis launches generic version of Pulmicort Respules
Flonase now available over the counter in the US
GSK has relied heavily on social media to get out the word that its Flonase fluticasone propionate nasal spray is now available over the counter in the United States. The FDA approved Flonase OTC in July 2014. On February 4, 2015, Flonase Twitter and Facebook accounts announced the availability of the … [Read more...] about Flonase now available over the counter in the US