Generics

JERUSALEM — Teva Pharmaceuticals introduced rivelsa (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets to its generic product line. This product is an authorized generic of Quartette tablets, and is available in 2 x 91 tablet dispensers. 
Rivelsa is an estrogen/progestin COC intended for use by women to prevent pregnancy.

EAST WINDSOR, N.J. — The Food and Drug Administration approved Aurobindo Pharma’s Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg. The Division of Bioequivalence determined Aurobindo Abacavir Sulfate and Lamivudine Tablets, 600 mg/300 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Epzicom Tablets of ViiV Healthcare.

MUMBAI, India — Lupin announced its Abacavir and Lamivudine tablets, 600 mg/300 mg, received Food and Drug Administration approval. Lupin’s Abacavir and Lamivudine tablets, 600 mg/300 mg, are the AB rated generic equivalent of ViiV Healthcare’s Epzicom tablets, 600 mg/300 mg. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Epzicom tablets had sales of $388.1 million (IMS MAT December 2016).

NEW ORELANS — Registration is now open for McKesson ideaShare 2017, which will take place in the Big Easy July 12–16, 2017 at the Ernest N. Morial Convention Center here. This year, the conference has been redesigned with an increased focus on connecting independent pharmacies with the tools and expertise needed to improve their clinical, operational and financial performance.

WASHINGTON — President Donald Trump’s choice to lead the Food and Drug Administration hopes to lower drug costs by approving cheaper generic drugs more quickly.

According to Bloomberg, former FDA Deputy Commissioner Scott Gottlieb would make streamlining drug approvals his top priority, with a particular focus on complex medications that combine old drugs with newer delivery devices, as well as ones with unusually complicated formulations. The news outlet added such changes in approach could come without Congressional approval.

EAST WINDSOR, N.J. — Aurobindo USA named Paul Krauthauser its SVP Commercial Operations, reporting to CEO Bob Cunard.

Krauthauser will be responsible for the retail generic business. He has more than 20 years of experience in U.S. pharmaceutical sales, including but not limited to demand planning, contracting and pricing and customer service functions. He most recently was SVP, sales and marketing at Rising Pharmaceuticals and has an extensive industry career with companies such as Sandoz and Teva Pharmaceuticals USA.

PISCATAWAY, N.J. — Camber Pharmaceuticals will introduce Oxycodone and Acetaminophen (APAP) Tablets, the generic version of Percocet tablets from Vintage Pharmaceuticals, which is used to treat moderate to moderately severe pain. Oxycodone APAP Tablets from Camber are available in 2.5/325mg, 5/325mg, 7.5/325mg and 10/325mg — 100- and 500-count bottles.

Camber anticipates shipping the drug in the second quarter.