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news.FDA accepts Sirion’s ophthalmic drug NDA
Sirion is seeking approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation. Priority review is granted by the FDA to
Sirion is seeking approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation. Priority review is granted by the FDA to
The company further expected that CyberMedx Medical Systems will become its newly-formed and third wholly-owned subsidiary. Gregory Vacca, CEO of WiFiMed, said: “We are very excited to announce
The company received approval for phendimetrazine tartrate tablets, 35mg the generic equivalent of Bontril tablets by Valeant Pharmaceuticals for the adjunct management of weight loss and buspirone tablets,
The application has been filed using the decentralized procedure with the Medicines and Healthcare Products Regulatory Agency of the UK serving as the reference member state with additional
Carbinoxamine maleate is a generic version of Pamlab’s Palgic oral solution. The company plans to launch its product immediately. Robert Edwards Jr., CEO of Boca Pharmacal, said: “Carbinoxamine
The purchase price for France Medica involves E5.4 million to be paid upon closing and E1.4 million to E1.7 million in earn-out payments based on the performance of
Arcalyst is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in CAPS. Regeneron expects to launch Arcalyst, its first commercial product, within the next 30
The medication is a generic version of Pfizer’s Camptosar. Hospira’s irinotecan product portfolio extends beyond the formulations available from the innovator. In addition to offering the medication in
A sample of the patient’s blood is processed with the CellSearch Kit using the CellTracks System to capture and count CTCs. This clearance represents another expansion to claims
The company’s reissue application seeks to correct these errors by deleting surplus compounds from the claims. Like most composition of matter patents claims many compounds in addition to