Generics

The Food and Drug Administration has approved Mumbai-based Lupin’s Tydemy. The product is a generic version of Bayer’s Safyral (drospirenone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg).

Tydemi is indicated as a contraceptive against pregnancy. The product had U.S. sales of approximately $22.9 million for the 12 months ended October 2017, according to data from IQVIA

The Food and Drug Administration has given full approval to Sanofi’s Admelog short-acting insulin lispro — a follow-on of Eli Lilly’s Humalog. The product received tentative approval from the FDA earlier this year, and now it is the first short-acting follow-on product to get the FDA’s stamp of approval.

Pfizer subsidiary Greenstone has introduced its authorized generic of Viagra (sildenafil citrate). The Peapack, N.J.-based company said that its generic would be available in 25-, 50- and 100-mg dosage strengths.

The erectile dysfunction drug had a market size of roughly $1.4 billion for the 12 months ended August 2017, according to IQVIA data. Greenstone noted that as a Pfizer subsidiary, the company is backed by Pfizer’s distribution and customer service support.

Amneal Biosciences is launching its generic of Kenalog-40 (triamcinolone acetonide injectable suspension, 40 mg/ml), with the Food and Drug Administration approved Tuesday. Bridgewater, N.J.-based Amneal said that its generic would be the only one available for the product.

“This important launch demonstrates the depth of our ability to successfully develop and manufacture complex products in our state-of-the-art manufacturing facilities,” Amneal co-CEO and co-chairman Chirag Patel said.

The Food and Drug Administration has approved specialty pharmaceutical company Impax Labs’ generic of GlaxoSmithKline’s Coreg CR (carvedilol phosphate) extended-release capsules.

Amneal’s biosciences arm recently introduced its generic of Clolar (clofarabine, 1mg/ml). The Bridgewater, N.J.-based company will be shipping the product in a single-dose vial containing 20 mg of the active ingredient in 20 ml of clear sterile solution.

“We are pleased to expand our product portfolio with clofarabine,” Amneal Biosciences president Charles Lucarelli said. “It’s an important addition to our growing oncology line.”

The product had $53 million in sales for the 12 months ended September 2017, according to data from IQVIA.

The Food and Drug Administration has approved Breckenridge Pharmaceuticals’ generic of Megace ES (megestrol acetate oral suspension).

The drug is a concentrated suspension that is indicated to treat loss of appetite, severe malnutrition or unexplained significant weight loss in patients with AIDS. The drug had generic and brand sales of $17.6 million for the 12 months ended October 2017, according to IQVIA data.

Mylan is launching its latest generic with its partner, South Africa-based Aspen. The companies are introducing their generic of Otsuka’s Myleran (busulfan, 6 mg/ml) injection.

The product is indicated in combination with cyclophosphamide as a conditioning regimen ahead of allogeneic hematopoietic progenitor cell transplantation in patients with chronic myelogenous leukemia. Mylan said that it has one of the largest injectables portfolios in the industry, and is among the leading cancer medicines suppliers by volume in the United States.