8 Significant Generic Drug Approvals Last Year

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:

• Alosetron (Lotronex) The FDA approved Roxane Laboratories Inc’s generic version of Lotronex in May 2015. Like its brand-name counterpart, alosetron is indicated to treat women with sever diarrhea-prominent irritable bowel syndrome who experience chronic symptoms and have not adequately responded to conventional therapy.

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.

• Darifenacin (Enablex) The FDA approved Par Pharmaceuticals’ generic darifenacin hydrobromide extended-release tablets in March 2015. The generic version of Enablex is indicated to treat overactive bladder and urinary incontinence. About 17% of women and 16% of men older than 18 years have overactive bladder, while an estimated 12.2 million adults across the United States experience from urinary incontinence.
• Eptifibatide (Integrelin) The FDA approved Teva Pharmaceuticals’ generic version of Integrelin in June 2015. Eptifibatide is an intravenous antiplatelet therapy indicated to treat acute coronary syndrome. It is currently on the FDA’s drug shortages list.
• Estradiol (Vagifem) The FDA approved Amneal Pharmaceuticals’ generic estradiol vaginal inserts in May 2015. The product is indicated to treat atrophic vaginitis due to estrogen loss associated with menopause. This condition is experienced by up to 75% of postmenopausal women.
• Levoleucovorin (Fusilev) The FDA approved Sandoz Inc.’s generic version of Fusilev in March 2015. Marketed in a single-use vial, levoleucovorin is indicated for rescue use after high-dose methotrexate therapy in bone cancer, in addition to diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and inadvertent overdosage of folic acid antagonists.
• Tetrabenazine (Xenazine) The FDA approved Sun Pharma’s generic tetrabenazine tablets in August 2015. The generic version of Xenazine is indicated to treat chorea associated with Huntington’s disease, a rare and fatal neurodegenerative disorder. The FDA granted Orphan Drug Designation to the drug in November 2014. According to the Huntington’s Society of America, just 1 in every 10,000 Americans has the disease.
• Tigecycline (Tygacil)

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.