NEW PRODUCT SPECIFIC GUIDANCES PUBLISHED ON FEB.

22

OTHER PRODUCTS (8)

•Bosentan tablets for suspension

PRODUCTS WITH NCE
EXCLUSIVITY (6) •Bromocriptine tablets

•Dexamethsone concentrate oral

•Acalabrutinib capsules
OFF PATENT OFF solution (1 mg/ml)
•Angiotensin II acetate IV solution EXCLUSIVITY PRODUCTS
WITH NO GENERICS* (8) •Diltiazem ER capsules
(Cardizem SR)
•Ivacaftor/Tezacaftor tablets
•Bexarotene gel
•Doxylamine/Pyridoxine tablets
•Ribociclib/Letrozole tablets
•Chlorothiazide suspension
•Loratidine Psuedoephedrine ER
•Fish oil, Medium chain triglycerides,
•Daptomycin 350 mg powder for IV tablets (OTC)
olive oil, soybean oil
(Smoflipid 20%) IV emulsion
•Dihydroergotamine nasal spray •Paroxetine Mesylate tablets
•Ozenoxacin topical cream
•Doxycycline calcium oral suspension •Acetaminophen; Caffeine;
Dihydrocodeine bitartarate(Trezix)
•Isocarboxazid tablets capsules

•Methsuximide capsules

•Succimer capsules
Pharmacaptions

*These products were observed in the FDA’s Off-Patent, Off-Exclusivity Drugs without an Approved Generic list (Accessed on 22 Feb. 2019). Source: fda.gov