Respiratory Tract Infections

• EMA approval · 2026-08-05
  EMA Authorised: Vantobra (previously Tobramycin PARI) (tobramycin) — Pari Pharma GmbH

  EMA authorized Vantobra (tobramycin) for respiratory tract infections including cystic fibrosis; MAH Pari Pharma GmbH; decision date 15/07/2…

• EMA approval · 2026-03-09
  EMA Authorised: Cayston (aztreonam lysine) — Gilead Sciences Ireland UC

  EMA authorised Cayston (aztreonam lysine) from Gilead Sciences Ireland UC for use in cystic fibrosis and related respiratory tract infection…

• EMA approval · 2025-12-11
  EMA Authorised: Tobi Podhaler (tobramycin) — Viatris Healthcare Limited

  EMA authorised Tobi Podhaler (tobramycin) for cystic fibrosis and respiratory tract infections; the marketing authorisation holder is Viatri…

• EMA approval · 2025-04-09
  EMA Authorised: Quinsair (levofloxacin) — Chiesi Farmaceutici S.p.A

  The European Medicines Agency has authorised Quinsair (inhaled levofloxacin) by Chiesi Farmaceutici for use in cystic fibrosis and related r…

• FDA approval · 2024-10-28
  FDA Approved: DOXYCYCLINE — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic doxycycline as an Original Application (ANDA 218053), enabling market entry of a doxycycl…

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• FDA approval · 2024-03-14
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for doxycycline, a generic antibiotic, expanding the availability of doxycycline pr…

• EMA approval · 2023-12-13
  EMA Authorised: Vantobra (previously Tobramycin PARI) (tobramycin) — Pari Pharma GmbH

  EMA has authorised Vantobra (tobramycin) for respiratory tract infections including cystic fibrosis, with Pari Pharma GmbH as the marketing …

• FDA approval · 2023-10-31
  FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…

• FDA approval · 2016-10-18
  FDA Approved: DOXYCYCLINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves a supplemental application for doxycycline from Lupin Pharmaceuticals, Inc. to modify/expand an existing generic product approv…

• FDA approval · 2012-04-25
  FDA Approved: DOXYCYCLINE HYCLATE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC)

  The FDA approved a supplemental application for doxycycline hyclate from Chartwell Governmental & Specialty RX, LLC, confirming regulatory s…

• FDA approval · 2011-05-04
  FDA Approved: CEPHALEXIN — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Cephalexin from AvKARE under ANDA 062713, authorizing continued manufacture and marketing of a C…