Regulatory Focus™ > News Articles > FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

Posted 09 March 2015 | By Alexander Gaffney, RAC

FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta.

The documents, known as bioequivalence recommendations, specifically apply to the Abbreviated New Drug Application (ANDA) process—the process by which generic drugs are approved.

Generic drugs, unlike new drugs, may be approved by FDA by showing that they are (among other things) bioequivalent to the drug they intend to reference. Bioequivalence can be shown in relatively small trials involving human subjects, which permits a company to avoid much larger—and much more expensive—full clinical trials required of new drug substances.

The bioequivalence guidance documents released by FDA last week explain how each generic drug company can test its products to ensure they pass FDA muster. Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for.

The documents are, in effect, a roadmap for regulatory approval for generic drug companies. The publication of a bioequivalence document does not, however, indicate that FDA will approve a generic drug product immediately. Patent and marketing exclusivity protections may still be in effect, which can preclude FDA approval or market access.

New Bioequivalence Guidance Documents

The new documents, along with a list of the brand name drugs they reference, are as follows:

Bioequivalence Guidance Dosage Form NDA  Brand Name Brand Name Manufacturer
Avanafil (PDF - 40KB)Tablet202276StendraVivus
Azilsartan kamedoxomil; chlorthalidone (PDF - 54KB)Tablet



202331EdarbyclorArbor Pharmaceuticals
 Buprenorphine HCl; Naloxone HCl (PDF -60KB)Film205637BunavailBiodevlivery Sciences
 Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride (PDF - 23KB)Tablet022113Advil Allergy and Congestion ReliefPfizer
Cyclosporine (PDF - 40KB)Capsule050625SandimmuneNovartis
Cyclosporine (PDF - 40KB)Capsule (modified)050715NeoralNovartis
 Deferiprone (PDF - 40KB)Tablet021825FerriproxApoPhrarma
 Desoximetasone  (PDF - 23KB)Spray204141TopicortTaro
 Diclofenac  (PDF - 23KB)Capsule204592ZorvolexIroko Pharmaceuticals


Diphenhydramine HCl; naproxen sodium (PDF - 23KB)

Tablet205352Aleve PMBayer Healthcare
 Dorzolamide HCl (PDF - 84KB)Solution/drops020408TrusoptMerck
 Doxepin HCl (PDF - 40KB)Capsule071669 Par Pharmaceuticals
Emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate (PDF - 42KB)Tablet202123CompleraGilead Sciences
Fluocinolone acetonide, hydroquinone, and tretinoin (PDF - 110KB)Cream21112Tri-LumaGalderma Labs


Ibrutinib (PDF - 23KB)

 Ibuprofen (PDF - 39KB)Capsule020402Advil Liqui-GelsPfizer
 Ipratropium bromide (PDF - 95KB)Aerosol, metered021527Atrovent HFABoehringer Ingelheim
 Isosorbide dinitrate  (PDF - 59KB)Tablet012093IsordilValeant Bermuda
 Isosorbide dinitrate (PDF - 59KB)Tablet087946 Par Pharmaceuticals
 Isotretinoin (PDF - 45KB)Capsule021951AbsoricaRanbaxy
 Ivacaftor (PDF - 39KB)Tablet203188KalydecoVertex
 Loperamide HCl (PDF - 41KB)Tablet, Chewable20448Imodium A-D EZ ChewsMcNeil Consumer Healthcare
Loperamide HCl (PDF - 41KB)Capsule021855 Banner Life Sciences
Loperamide HCl (PDF - 41KB)Capsule17694ImodiumMcNeil Consumer Healthcare
Loperamide HCl (PDF - 40KB)Suspension19487Imodium A-DMcNeil Consumer Healthcare
Loperamide HCl (PDF - 41KB)Tablet19860Imodium A-DMcNeil Consumer Healthcare
Lorcaserin HCl(PDF - 42KB)Tablet22529BelviqEisai
Minocycline HCl (PDF - 113KB)Powder, Extended Release50781ArestinOrapharma
Oxybutynin chloride (PDF - 42KB)Tablet075079 Vintage Pharmaceuticals


Potassium chloride (PDF - 37KB)


Tablet, Extended Release018279K-TabAbbvie
 Praziquantel (PDF - 42KB)Tablet18714BiltricideBayer
 Pyrimethamine  (PDF - 22KB)Tablet008578DarprimAmedra
 Sodium polystyrene sulfonate  (PDF - 16KB)Powder011287KayexalateCovis Pharmaceuticals


Sucroferric oxyhydroxide (PDF - 26KB) 


Tablet, Chewable205109VelphoroVifor Fresenius
Ticagrelor (PDF - 41KB)Tablet022433BrilintaAstraZeneca
Topiramate (PDF - 27KB)Capsule, Extended Release205122Qudexy XRUpsher Smith
Topiramate  (PDF - 25KB)Capsule, Extended Release201635Trokendi XRSupernus Pharmaceuticals
Vigabatrin  (PDF - 42KB)Tablet20427SabrilLundbeck



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