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First-time generic approvals
First-time generic approvals
First-time generic approvals
Valacyclovir tablets, 500 mg (base) and 1 g (base) (equiv to Valtrex caplets)
RANBAXY
Albuterol sulfate extended-release tablets, 4 mg (base) and 8 mg (base) (equiv to VoSpire ER tablets)
MYLAN
Fentanyl-12 transdermal system, 12.5 mcg/h (equiv to Duragesic-12)
MYLAN
Dexmethylphenidate tablets, 2.5, 5, and 10 mg (equiv to Focalin tablets)
TEVA
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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