Federal Register Notice: FDA is making available items that were omitted and correcting a 5/31 draft guidance on bioequivalence (BE) recommendations for specific products. The recommendations provide guidance on the design of BE studies to support ANDAs.
Those products that were not posted on FDA’s Web Site and are now available are: (1) Ganciclovir (2) Ibuprofen; Pseudoephedrine HCl (3) Felbamate (multiple dosage forms) (4) Leflunomide.
Recommendations for products posted on the Web site that were not listed in 5/31 Federal Register Notice announcing the guidance are: (1) Fosinopril Sodium (2) Hydrochlorothiazide and Irbesartan (3) Levonorgestrel (4) Lidocaine (5) Loratadine (6) Phenytoin Sodium (multiple RLDs) (7) Phenytoin (8) Terazosin HCl C.
Recommendations listed in the notice and posted on the Web site that were incorrect are for (1) Mycophenolate mofetil tablet 50723, corrected the analytes to measure (2) Mycophenolate mofetil capsule 50722, corrected the analytes to measure (3) Erlotinib HCl tablet, deleted the IND requirement (4) Hydrochlorothiazide and losartan potassium tablets, added waiver strength 12.5 mg/100mg. To view this notice, click here.