Regulatory
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 11 to 2 in favor of approval for GSK’s Anoro Ellipta umeclidinium/vilanterol dry powder inhaler for the treatment of COPD, according to GlaxoSmithKline and Theravance. The… Read more . . .
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The FDA has issued a draft guidance on bioequivalence recommendations for generic fluticasone propionate/salmeterol xinafoate inhalers. Notice of the draft guidance appeared in the Federal Register for September 10, 2013. According to the agency, public… Read more . . .
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Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing… Read more . . .
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Health Canada has announced that it is withdrawing marketing authorization for calcitonin nasal sprays as of October 1, 2013 due to concerns about cancer risks associated with the products. Injectable calcitonin products will continue to… Read more . . .
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The FDA has announced that its Pulmonary-Allergy Drugs Advisory Committee (PADAC) will hold a public meeting on September 10, 2013 to discuss Glaxo’s NDA for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD.… Read more . . .
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According to Sanofi, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If… Read more . . .
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Patient advocacy organization Allergy & Asthma Network Mothers of Asthmatics (AANMA) has released data from a survey of patients using intranasal corticosteroid sprays showing that 90% of the patients surveyed “said they prefer to rely… Read more . . .
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Novartis has announced that its Ultibro Breezhaler indacaterol/glycopyrronium DPI (QVA149) has gotten a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of COPD. The company filed an… Read more . . .
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GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the companies say. Review of the JNDA, which… Read more . . .
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GlaxoSmithKline has announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved for the treatment of COPD in Canada. GlaxoSmithKline Inc. President Paul Lirette said, “For over forty years, GlaxoSmithKline has been at the… Read more . . .
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