Generics

The Food and Drug Administration is moving full speed ahead into the new year, releasing two documents Wednesday as part of its ongoing Drug Competition Action Plan. The documents are aimed at making the generic approval process speedier and reducing the number of review cycles for abbreviated new drug applications, or ANDAs.

The Food and Drug Administration has issued tentative approval to Perrigo for its generic of Bausch & Lomb’s Prolensa (bromfenac ophthalmic solution, 0.07%). The product is indicated to treat post-operative inflammation and reduce ocular pain in cataract surgery recipients.

Dublin-based Perrigo said it has previously settled litigation with Bausch & Lomb regarding the product. Prolensa’s U.S. brand sales for past 12 months were $113 million, Perrigo said.

The Food and Drug Administration has approved Lupin’s generic of Leo Pharmaceutical Products’ Dovonex Scalp Solution (calcipotriene topical solution, 0.005%). The product is indicated for the topical treatment of moderately severe psoriasis on the scalp.

According to IQVIA data, the product had U.S. sales of roughly $5.9 million for the 12 months ended October 2017.

Mylan has announced the launch of its Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace cream. The company received final approval from the U.S. Food and Drug Administration for the product which is intended to treat vulvar and vaginal atrophy.

Dr. Reddy’s has announced the launch of melphalan hydrochloride for injection, which has been approved by the Food and Drug Administration. This latest product is a therapeutic equivalent generic version of Alkeran.

The company’s Melphalan Hydrochloride for injection is available in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.

Teva has introduced its generic of Reyataz (atazanavir) capsules within the United States, the company announced. The drug is indicated to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients six years old and older who weigh at least 15 kg.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.

Amneal also launched five other products in addition to sevelamer carbonate:

The Food and Drug Administration recently approved Pfizer’s Ixifi (infliximab-qbtx), the company’s second approved biosimilar of Janssen’s Remicade. The biosimilar was approved for all of Remicade’s indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and plaque psoriasis, among others.

The approval follows the April 2016 launch of its first Remicade biosimilar Inflectra. According to reports, Pfizer has said it has no plans to launch Ixifi in the United States.