According to Vectura, its partner Hikma Pharmaceuticals has received a complete response letter from the FDA to its ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK's Advair Diskus. Vectura said that the CRL was categorized as "Major" and added, "Based on the initial assessment no material issues were raised regarding the substitutability … [Read more...] about Hikma gets CRL for its generic version of Advair Diskus
Regulatory
Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
The IMPALA Phase 2/3 trial for Savara's Molgradex inhaled molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) will be modified in order to qualify as a pivotal study for a US regulatory submission, the company said. According to Savara, the FDA has provided guidance on increasing enrollment and changing endpoint hierarchy and analysis … [Read more...] about Savara to modify Phase 2/3 Molgradex trial to qualify as pivotal study in US
Evoke Pharma reports agreement with FDA regarding PK trial design for Gimoti
According to Evoke Pharma, the company has reached an agreement with the FDA on design of a PK trial for its Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The company said that results of the PK trial are expected later this year, with an NDA submission expected no later than early 2018. The company has previously announced that the … [Read more...] about Evoke Pharma reports agreement with FDA regarding PK trial design for Gimoti
Mylan gets complete response letter for generic Advair ANDA
Mylan has announced that it received a complete response letter from the FDA in regards to its ANDA for a generic version of GlaxoSmithKline's Advair Diskus fluticasone/salmeterol DPI. The company said that it is reviewing the CRL and will comment further once it has discussed it with the FDA. In February 2016, Mylan announced that the FDA had accepted its ANDA for … [Read more...] about Mylan gets complete response letter for generic Advair ANDA
FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
The FDA has denied a citizen petition filed by Sandoz in October 2016 in which Sandoz challenged the agency's 2013 bioequivalence recommendations for generic versions of Advair Diskus fluticasone propionate/salmeterol xinafoate. However, in a copy of the March 10, 2017 response letter posted by Fierce Pharma, the FDA said that it "has made no final determination … [Read more...] about FDA responds to Sandoz’s citizen petition on Advair bioequivalence recommendations
FDA approves Lupin’s generic TOBI inhalation solution
Lupin announced that the FDA has granted final approval for the company's tobramycin inhalation solution, a generic version of Novartis's TOBI 300 mg/5 ml inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. The company noted that US sales of tobramycin inhalation solution in 2016 totaled $133.6 million. Read the … [Read more...] about FDA approves Lupin’s generic TOBI inhalation solution
FDA warns Wockhardt subsidiary over fluticasone propionate nasal spray manufacturing and testing violations
A February 17, 2017 FDA warning letter to Wockhardt subsidiary Morton Grove Pharmaceuticals cites numerous cGMP violations, including several related to the manufacture of fluticasone propionate nasal spray. Wockhardt's generic fluticasone propionate nasal spray was approved by the FDA in January 2012. The letter states that "During our inspection, we observed … [Read more...] about FDA warns Wockhardt subsidiary over fluticasone propionate nasal spray manufacturing and testing violations
FDA approves Noctiva desmopressin nasal spray for the treatment of nocturnal polyuria
The FDA has announced the approval of Noctiva desmopressin acetate nasal spray for the treatment of nocturnal polyuria (overproduction of urine at night). Allergan licensed SER120 desmopressin nasal spray from Serenity Pharmaceuticals in 2010. In 2007, the FDA announced that intranasal desmopressin was no longer indicated for the treatment of nocturnal enuresis … [Read more...] about FDA approves Noctiva desmopressin nasal spray for the treatment of nocturnal polyuria
Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version
Adapt Pharma has filed a marketing authorization application in Europe for its naloxone nasal spray for the treatment of opioid overdose, the company said. Adapt's naloxone nasal spray, marketed as Narcan, has been approved in the US since 2015 and in Canada since 2016. The FDA also approved a lower dose of formulation of Narcan in January 2017. Meanwhile, … [Read more...] about Adapt files MAA for its naloxone nasal spray, Amphastar gets CRL for its version
Spiriva Respimat approved by FDA for pediatric use
The FDA has approved Boehringer Ingelheim's sNDA for the use of Spiriva Respimat to treat asthma in patients aged 6 and older and has granted pediatric exclusivity for the product, the company announced. Spiriva Respimat was approved for the treatment of asthma in patients 12 and older in the US in September 2015. Boehringer Ingelheim Pharmaceuticals Senior VP, … [Read more...] about Spiriva Respimat approved by FDA for pediatric use