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Diplomat added to limited-distribution network for Cornerstone Therapeutics' Bethkis
FLINT, Mich. — Cornerstone Therapeutics has added specialty pharmacy Diplomat to its limited-distribution network for a newly approved treatment for cystic fibrosis, Diplomat said Friday.
Diplomat will distribute Bethkis (tobramycin inhalation solution), which received Food and Drug Administration approval in October for treating chronic bacterial lung infections caused by P. aeruginosa in cystic fibrosis patients.
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FDA wants more clinical trial data before approving Forest, Gedeon Richter psychiatric drug
NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.
The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug's efficacy, but wanted more clinical trial data.