The FDA approved 700 generic drugs in 2015.
The FDA approved 700 generic drugs in 2015, constituting a banner year in the agency’s efforts to clear its generic backlog.
The FDA’s Office of Generic Drugs (OGD) released a report touting the agency’s achievements just 2 months after the US Senate held a hearing to investigate the culprits behind the growing backlog of generic drug applications. The issue at hand was the status of the Generic Drug User Fee Act (GDUFA) of 2012, which affords the FDA additional Congressional funding for a period of 5 years to facilitate faster generic drug approvals.
GDUFA requires generic industry stakeholders to pay user fees to supplement the costs associated with reviewing generic drug applications and inspecting facilities faster. These fees are intended to ultimately help applicants market their drugs earlier.
At the time of the law’s passage, the FDA’s generic approval backlog included 3866 abbreviated new drug applications (ANDA) and 1873 prior approval supplements (PAS).
By the end of December 2015, the agency had taken action on 84% of ANDAs and 88% of PASs.
In a blog post prefacing the report’s release, OGD Director Kathleen Cook, MD, said it’s been an “important year for advancing generics” and the FDA is “on track for meeting all [GDUFA] goals.”
The agency deems a drug approval “significant” when it “represents[s] the first time a generic for this drug has been approved, serve[s] an underserved public health need, or address[es] drug shortages,” Dr. Cook explained.
Here’s a list of generic drug approvals that the FDA deemed “significant” in 2015:
2. Aripiprazole (Abilify)
The FDA approved generic aripiprazole tablets of various dosage strengths from 4 different manufacturers all on the same day in April 2015.
The generic versions of Abilify are indicated to treat schizophrenia and bipolar disorder.
“Having access to treatments is important for patients with long-term health conditions [and] health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug,” stated John Peters, MD, acting director of OGD at the time of the generics’ approval.
FDA approved Sandoz’s generic tigecycline in May 2015. The generic version of Tygacil is a bacteriostatic glycylcycline antibiotic derived from minocycline and indicated to treat pneumonia and other serious infections.