It seems that FDA is updating its First Generic Approvals list a bit more frequently. As reported on May 17 (here) the number of First generic Approvals was 43 (please read that post for the definition of first generic approval and other interesting information about the report).
Yesterday the FDA updated its list through May 31, 2019 and now reports 49 First Generic Approvals. There were no duplicate listings for the six products added (here). Among the newly first generics are:
- Sildenafil for Oral Suspension, 10 mg/mL (for the treatment of pulmonary arterial hypertension not ED)
- Dapiprazole Hydrochloride Ophthalmic Solution, 0.5% (for the treatment of iatrogenically induced mydriasis)
- Micafungin for Injection, 50 mg/vial and 100 mg/vial (for the treatment candidemia)
- Sapropterin Dihydrochloride Tablets, 100 mg (for the reduction of blood phenylalanine (Phe) levels)
- Mesalamine Delayed-Release Capsules, 400 mg (for the treatment of mildly to moderately active ulcerative colitis) the treatment of mildly to moderately active ulcerative colitis (for the treatment of Wilson’s disease)
With the number of first generics being reported in the first 5 months of the year, it is possible that we could see greater than 100 new entries into the approved first generic space by the end of the year. But remember, as explained previously, approval does not guarantee immediate market entry!.
