August 16, 2017

The drug is indicated to treat cutaneous candidiasis. It had a U.S. market size of $93 million for the 12 months ended June 2017.

August 15, 2017

A recent Food and Drug Administration public meeting kicked off a two-month comment period during which stakeholders have been encouraged to share their input on how best to improve generic competition and what current barriers exist.

August 15, 2017

For the 12 months ended June 2017, the drug had U.S. sales of $122.4 million, according to QuintilesIMS data.

August 10, 2017

Mylan has invested $250 million in expanding its antiretroviral production capabilities, enabling it to produce 4 billion antiretroviral tablets and capsules each year, the company said.

August 9, 2017

The drug had U.S. sales of $272 million for the 12 months ended June 2017, according to QuintilesIMS data. 

August 4, 2017

The drug is indicated to treat persistent (nontransient) erythema of rosacea in adults ages 18 years and older. 

August 3, 2017

The bill contains the reauthorizations of the Food and Drug Administration’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

August 2, 2017

In addition to rolling out new value-focused initiatives, CVS Health said it would be removing 17 drugs from its Standard Control Formulary in 2018 

August 2, 2017
The drug is indicated to treat migraine headaches.
July 31, 2017

The drug is indicated to relieve inflammatory and pruritic manifestations of dermatoses that are responsive to corticosteroid treatment. 

July 31, 2017

Greenstone’s authorized generic will be available in 20- and 40-mg dosage strengths in blister packs of six tablets per card.

July 31, 2017

The patch had U.S. sales of approximately $158 million for the 12 months ended May 2017.

July 28, 2017

The combination medicine is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years and older.

July 28, 2017

The topical treatment is for patients nine years and older with acne vulgaris.

July 25, 2017

JERUSALEM — Teva on Monday announced the launch of its generic Vagifem (estradiol vaginal inserts). The drug is indicated to treat atrophic vaginitis due to menopause.

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.