FDA Looks To Solve Chantix Shortage With Par ANDA Approval
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Endo’s Par looks set to provide much needed supply in the US market for varenicline tablets, after originator Pfizer ran into supply and distribution problems due to the presence of a nitrosamine for its Chantix original.
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Endo’s Par generics unit has launched the first US generic version of Pfizer’s Chantix (varenicline) tablets, entering the market just after the originator recalled the brand over nitrosamine impurities.
Endo enters into an agreement with the subsidiaries of Strides Pharma to sell its manufacturing site in Chestnut Ridge, New York. Meanwhile, the company sees a double-digit drop in its generics business. Furthermore, Endo executes settlement resolving all opioid-related claims in Tennessee.
Cipla signals more US momentum with headroom for albuterol market share expansion, promising prospects for generic Brovana and strong launch line-up in FY23, but analysts also keep close eye on regulatory pre-approval inspection timelines.