Generics

PITTSBURGH — Mylan introduced Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer's Pristiq Tablets, in the United States.

Desvenlafaxine is indicated for the treatment of a major depressive disorder. Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, had U.S. sales of approximately $853 million for the 12 months ending January 31, 2017, according to IMS Health.

WASHINGTON — Legislation intended to require the U.S. Food and Drug Administration to act upon applications for generic drugs within 180 days of being filed that are in short supply or when there are too few manufacturers on the market is being revised, a House Energy and Commerce Committee aide told Bloomberg.

BALTIMORE — Lupin has launched its Clobetasol Propionate Topical Solution USP, 0.05%.

Clobetasol is the generic equivalent of Fougera Pharmaceuticals’ Temovate (clobetasol propionate) Scalp Application, 0.05%. It is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.

Temovate Clobetasol Propionate Scalp Application had an estimated U.S. sales of USD 64.1 million in 2016.

WOONSOCKET, R.I. — Prescriptions for EpiPen alternatives have quadrupled since quadrupled since the beginning of 2017, with non-EpiPen epinephrine auto-injector prescriptions share reaching 28.9% for the period of Feb. 1-Feb. 25, according to athenaResearch.

WASHINGTON — Reps. Doug Collins, R-Ga., and Dave Loebsack, D-Iowa, on Thursday introduced H.R. 1316, the Prescription Drug Price Transparency Act, to protect taxpayers and the community pharmacists who serve them by requiring greater transparency from pharmacy benefit managers.

DUBLIN — The U.S. Food and Drug Administration approved Perrigo’s Abbreviated New Drug Application referencing a generic for Eli Lilly’s Axiron Topical Solution, 30 mg/1.5 mL (Testosterone Topical Solution, 30 mg/1.5 mL).

Axiron Topical Solution, 30 mg/1.5 mL is indicated to treat adult males who have low or no testosterone due to certain medical conditions. Annual sales for the 12 months ending January 2017 were approximately $254 million.

JERUSALEM, Israel — Teva Pharmaceuticals on Wednesday introduced generic Pristiq (desvenlafaxine) extended-release tablets, 25, 50 and 100 mg, in the United States.

Desvenlafaxine extended-release tablets, a SNRI, are indicated for the treatment of major depressive disorder. The efficacy of desvenlafaxine extended-release tablets has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for MDD.