Sun shines on FDA to expedite Doxil generic approval

By Dan Stanton

- Last updated on GMT

FDA push through approval of Doxil generic
FDA push through approval of Doxil generic

Related tags Food and drug administration

Sun Pharma says it is confident that all quality issues are covered as its Doxil generic gets hurried approval from the FDA.

Following a string of manufacturing issues at Ben Venue Laboratories plant culminating in last week’s consent decree from the US Food and Drug Administration​ (FDA), a generic version of cancer drug Doxil – marketed by J&J’s offshoot Janssen - has been approved.

Sun Pharma Global who are manufacturing and supplying the generic is confident that the problems surrounding Doxil will not apply. Mira Desai, a Sun spokeswoman, told that “there are no compromises”​ when it comes to quality assurance and control.

Desai couldn’t comment on Ben Venue’s facilities but did say that Sun’s site “is a running plant that manufactures for world markets and has been USFDA approved since 1987.”

Drug shortage 

The approval of the Doxil generic has been accelerated as part of FDA measures to avoid further shortages of necessary drugs and in order to withdraw last February's enforcement discretions on any unapproved doxorubicin liposome drug (Doxil equivalent), issued at the height of the Doxil shortage.

Lipodox, Sun’s own brand of doxorubicin liposome, was one alternative to Doxil which was imported​ following the FDA’s emergency decree.

Speaking with, Stephen King, Public Affairs Specialist at the FDA’s Center for Drug Evaluation and Research ensured that “Sun’s ANDA (abbreviated new drug application) was evaluated under the same rigorous standards that FDA always applies to generics.”​ 

He continued, adding: “If it were not for the shortage, the review of the Sun ANDA for doxorubicin liposomal would not have been expedited and probably would not be ready for approval at this time.”​ 

The ANDA will be manufactured at Sun’s Halol facility (in Gujarat, India) which has been producing Lipodox for the Indian market for nearly ten years. Following recent inspections, the plant has been deemed to be compliant with the FDA’s current good manufacturing practices.

Sun’s ANDA will be marketed for a wide range of cancers though Doxil has orphan drug exclusivity until May 2014 for the treatment of multiple myeloma.

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