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First-time generic approvals (July 2006)
Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)
Colestipol for oral suspension, 5 g/packet or scoopful (equiv to Colestid)
IMPAX
Ketotifen ophthalmic solution, 0.025% (equiv to Zaditor ophthalmic solution)
Cefdinir capsules, 300 mg (equiv to Omnicef capsules)
LUPIN LIMITED
Cefdinir for oral suspension, 125 mg/5 mL (equiv to Omnicef for oral suspension)
LUPIN PHARMACEUTICALS
Escitalopram tablets, 5, 10, and 20 mg (equiv to Lexapro tablets)
IVAX
Metronidazole topical lotion, 0.75% (equiv to Metrolotion topical lotion)
Altana
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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