FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
“FDA adopted this process as a means to develop and disseminate product-specific BE [bioequivalent] recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations,” according to the notice.
Related: Specialty pharmaceuticals roundtable: Balancing benefits, cost
The bioequivalence recommendations apply to the Abbreviated New Drug Applicaton (ANDA) process and affect popular drugs such as avanafil (Stendra, Endo), lorcaserin HCl (Belviq, Eisai) and ticagrelor (Brilinta, AstraZeneca). FDA’s new draft guidance for industry on product-specific BE recommendations includes drug products containing the following active ingredients: avanafil, azilsartan kamedoxomil; chlorthalidone, buprenorphine HCl; naloxone HCl; chlorpheniramine maleate; ibuprofen; cyclosporine; deferiprone; desoximetasone; diclofenac; diphenhydramine HCl; naproxen sodium, loperamide HCl, minocycline HCl, oxybutynin chloride, potassium chloride and pyrimethamine.
Related: Biosimilar drugs could save US millions
Interested parties must submit either electronic or written comments on the draft by May 8, 2015.
The guidance stems back to FDA’s Federal Register notice of June 11, 2010, (75 FR 33311), when FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products."
Read next: The rising cost of generic drugs
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More