July 24, 2017

At a public meeting on July 18, Food and Drug Administration commissioner Scott Gottlieb said that by the end of the year, the agency would develop an internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.

July 24, 2017

he company said that Renflexis would be launched with a wholesaler acquisition cost of $753.39, which it said is a 35% discount to Remicade’s current list price. 

July 21, 2017

The drug has met all of the Food and Drug Administration's requirements but is facing an automatic stay as the result of litigation with Sanofi, who has claimed patent infringement on it Lantus insulin. 

July 21, 2017

SILVER SPRING, Md. — The Food and Drug Administration has given Teligent approval for its third approval this year. The company announced the approval of its generic of Erygel (Erythromycin Topical Gel, 2%) on Friday.

“Teligent now has 19 topical generic pharmaceutical products in the US portfolio, in addition to our four U.S. injectable products,” Teligent president and CEO Jason Grenfell-Gardner said.

July 19, 2017

Perrigo said that it anticipates launching the generic ear drops within 90 days.

July 18, 2017
The organization has named Kristin Murphy its director of federal affairs, promoting Michael Brzica to the role of VP federal government affairs.
 
July 18, 2017

The combined products have a market size of $315.9 million for the 12 months ended May 2017 according to QuintilesIMS data.

July 17, 2017

The drug had U.S. sales of approximately $1.8 billion for the 12 months ended May 2017, according to QuintilesIMS data.

July 17, 2017

The drug had annual U.S. sales of $88 million for the 12 months ended May 2017, according to QuintilesIMS data.

July 17, 2017

Jean Coutu founder Jean Coutu spoke out regarding negotiations with Quebec around dispensing fees, according to a report published last week by Canada's Bell Media. Jean Coutu earlier this year agreed to surrender $300 million in collected dispensing fees in return for smaller manufacturer rebates that cut into pharmacy operating margins. "It is an average of $100,000 for each of our locations," Coutu told shareholders BellMedia reported. "It was extremely difficult to digest." (Bell Media)

July 14, 2017

Mike Hotra joins the organization as VP of its public affairs team, and Ken McKay is the advocacy organization’s new VP state government affairs. 

July 11, 2017

Rachel Sher was most recently a senior policy analyst in the Food and Drug Administration’s Office of Policy.

 
July 11, 2017
The company now offers 25- and 35-mg dosage strengths of its generic of Focalin XR extended-release tablets. 
July 6, 2017

The approval adds to the 5-, 10-, 15-, 20- and 30-mg capsules the company has previously launched of the generic.

July 6, 2017

Vigamox ophthalmic solution had U.S. sales of approximately $267.9 million, according to Quintiles IMS data for the 12 months ended March 2017.

July 5, 2017

Advent International is buying the Mexican private generics leader from Endo for roughly $124 million. 

July 5, 2017

The drug had annual market sales of $248 million for the 12 months ended April 2017.

June 30, 2017

Under the agreement, Sandoz will develop and commercialize a generic of a major inhaled combination therapy delivered using a pressurized metered dose inhaler that Vectura Group is developing. 

June 29, 2017

The company said that the creams had combined U.S. sales of $38 million for the 12 months ended Aril 2017, according to QuintilesIMS data.

June 29, 2017

The drug had combined sales of $188 million for the 12 months ended April 2017, the company said.

June 28, 2017

Patients with diabetes who create an account on the Blink Health website or mobile app will be able to receive a year’s supply of metformin, glipizide and pioglitazone for free. 

June 28, 2017

The Food and Drug Administration has shared a list of drugs without patents or exclusivity that don't yet have generics, and has outlined a new plan for expediting review of generics of drugs with limited competition.

June 27, 2017

The drug is indicated to treat schizophrenia and to control severe nausea and vomiting in adults.

June 26, 2017

Born in Rajgarh, Rajasthan, Gupta moved to Mumbai and founded Lupin in 1968 with the goal of providing high-quality medicines at affordable prices.