October 12, 2016
The drug had $133 million in U.S. sales for the 12 months ended July 2016, according to IMS Health. 
 
October 10, 2016

The Dr. Reddy’s generic will be available in 25-, 50-, 100- and 200-mg dosage strengths in 30-count bottles.

October 7, 2016

HDA's Perry Fri will continue to serve in his current role as EVP industry relations, membership and education for HDA.

October 6, 2016

Teva and Celltrion on Thursday announced a new exclusive partnership centered on commercializing two of Celltrion’s biosimilar candidates in the United States and Canada. 

October 5, 2016

JD Supra is reporting that the Supreme Court has declined to hear a case between Amphastar Pharmaceuticals and Momenta Pharmaceuticals concerning whether the scope of safe harbor within the Hatch-Waxman Act extends to a generic manufacturer doing bioequivalence testing that’s performed to maintain FDA approval and documented. The Federal Circuit’s ruling that Amphastar’s post-approval testing fell outside of safe harbor protection will remain in place as a result. (JD Supra)

October 5, 2016
The sale to Accord Healthcare will include a portfolio of generics, as well as a Barnstaple, England manufacturing plant.
October 3, 2016

Fred’s announced Monday that its wholly-owned specialty pharmacy, Eiris Health Services has a new name.

October 3, 2016
When the acquisition was announced, it was valued at $500 million, and it brings  the fourth-largest U.S. generics distributor under Teva’s ownership. 
September 30, 2016
Mylan’s generic will be available in 500- and 1000-mg dosage strengths.
September 29, 2016
Lupin’s generic of Namenda XR will be available in 7-, 14-, 21- and 28-mg dosage strengths. 
September 28, 2016

Camber’s generic will be available in 30-count bottles of 20-, 30- and 60-mg dosage strengths, as well as 90-count bottles of the 30-mg capsules. 

September 28, 2016
Teva’s generic will be available in 600-mg abacavir/300-mg lamivudine dosage strength. 
September 27, 2016

Apotex has re-entered the market with its generic Floxin Otic (ofloxacin otic solution, 0.3%). 

September 27, 2016
Under the agreement, Pharmathen will develop, manufacture and supply a generic product in a $500 million category, and Upsher-Smith will submit the product for Food and Drug Administration approval and handle marketing and distributing in the United States as an Upsher-Smith generic. 
 
September 26, 2016
Ajanta’s generic will be available in 20- and 40-mg omeprazole/1680-mg sodium bicarbonate dosage strengths. 
September 26, 2016

Amjevita is the fourth approved biosimilar in the United States, and Amgen’s first approved biosimilar. 

September 23, 2016

The company announced Tuesday that its board of directors had named Paul Campanelli to the position, effective immediately, succeeding Ravid De Silva, who has stepped down from the position and his place on the company's board of directors. 

September 22, 2016

This is the first approval for a generic of Tivicay (dolutegravir), an HIV treatment recommended by the World Health Organization and the Centers for Disease Control and Prevention. 

 
September 22, 2016

Impax’s generic will be available in 10-, 20-, 30-, 40-, 50- and 60-mg dosage strengths.

September 21, 2016

ATLANTA - The total economic burden attributed to opioid abuse exceeds $78 billion, according to a recent report published in Medical Daily. "More than 40 Americans die each day from overdoses involving prescription opioids. Families and communities continue to be devastated by the epidemic of prescription opioid overdoses." Tom Frieden, director Centers for Disease Control Director shared with Medical Daily. "The rising cost of the epidemic is also a tremendous burden for the health care system." (Medical Daily)

September 20, 2016

As drug costs again become a topic of national conversation, Chip Davis, president of the Generic Pharmaceutical Association, has weighed in on the issue. 

September 20, 2016
BioPharmaDIVE is reporting on a recently filed lawsuit from Sanofi contending that Merck & Co. infringed on its patents for Lantus (uinsulin glargine) and its insulin delivery device soloSTAR. The lawsuit follows Merck’s announcement that it had filed a New Drug Application with the Food and Drug Administration for follow-on biologic insulin glargine product. It has previously sued Eli Lilly & Co., alleging that its insulin biosimilar infringed on its patents, which delayed the launch of Lilly’s Basalgar until December. (BioPharmaDIVE)
 

 

September 19, 2016

The drug had about $22.5 million in U.S. sales for the 12 months ended July 2016, according to IMS Health

September 19, 2016

Both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization issues statements in support of the letter.