US FDA Releases Slew Of Guidances On A Fell Day For Complex Generics
New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.
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Teva is lining up another complex ANDA product after agreeing to settle litigation with Collegium Pharmaceutical over the Israeli firm’s proposed generic version of Xtampza ER (oxycodone) extended-release capsules.
The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.
FDA issued a complete response letter for Hikma's ANDA to market a generic version of GSK's Advair, the second application to be rejected by FDA.