New Drug Application

FDA Accepts New Drug Application for Postoperative Ocular Pain, Inflammation

FDA Accepts New Drug Application for Postoperative Ocular Pain, Inflammation

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The FDA has accepted a New Drug Application for an investigational topical twice-a-day product for the treatment of inflammation and pain in patients who have undergone ocular surgery.

FDA Grants Priority Review to Lofexidine for Management of Opioid Withdrawal Symptoms

FDA Grants Priority Review to Lofexidine for Management of Opioid Withdrawal Symptoms

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US WorldMeds announced that the Food and Drug Administration has accepted for Priority Review the New Drug Application for lofexidine to manage the symptoms associated with opioid withdrawal and to facilitate completion of opioid discontinuation treatment.

Lasmiditan Effective in Phase 3 Trial for Acute Migraine

Lasmiditan Effective in Phase 3 Trial for Acute Migraine

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Eli Lily announced positive results from a Phase 3 trial of their first-in-class drug lasmiditan for the acute treatment of migraine.

FDA Policy Seeks to Increase Number of Generics on Market

FDA Policy Seeks to Increase Number of Generics on Market

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The FDA has announced a new policy to expedite reviews of generic drug applications in cases where competition is limited.

FDA Approves Zilretta NDA for Knee Osteoarthritis

FDA Approves Zilretta NDA for Knee Osteoarthritis

The Food and Drug Administration has accepted for review the New Drug Application for Zilretta for the treatment of patients with osteoarthritis of the knee.

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