Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...

A group of 20 Senate democrats on Tuesday sent a letter to Mylan CEO Heather Bresch, questioning her about her company's actions in response to criticism over price increases for its life-saving EpiPen, which rose in price more than 400% over the past decade. The letter comes just one day after the House Oversight and Government Committee launched an investigation into Mylan's "virtual monopoly over the epinephrine auto-injector market." In a separate letter to Bresch se...

As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced on Monday that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks , will have a list price of $300, which is half the list price of the brand product, but still significantly more than the price was prior...

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector. The letter comes amid a frenzy of Congressional outrage over the more than 400% spike in the price of Mylan’s life-saving EpiPen for those suffering from severe allergies that hasn’...

Sen. Amy Klobuchar (D-MN) this week called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies. Klobuchar joined fellow Democrat on the Judiciary Committee, Sen. Richard Blumenthal (D-CT), as well as former presidential hopeful Sen. Bernie Sanders (D-VT) in expressing outrage over the price hikes. And on Wednesday, Democrat...

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance aiming to improve the way adhesion data is used for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches. The draft guidance, released in May , describes the recommended approach for an adhesion clinical study design and, once finalized, the guidance will sup...

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the  Biologics Price Competition and Innovation Act  (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period. The provision in the BPCIA in question states that: "An approved application for a ...

Mylan subsidiary Agila Specialties has received a statement of good manufacturing practice (GMP) non-compliance from Poland’s Main Pharmaceutical Inspectorate at its Warsaw-based manufacturing site. Polish regulators found 29 major deficiencies posing a risk of microbial and particulate contamination, most of which were linked to the design and qualification of air flow systems and clean areas, cleaning and maintenance, manufacturing and batch releases that do not comply...

The Federal Trade Commission (FTC) on Thursday criticized the way brand-name drug manufacturers often tweak products' formulations shortly before a generic's entry to market, thereby delaying competition. The practice, commonly known as "product hopping," can end up harming consumers as it impedes competition "from would-be generic entrants, which have sought FDA approval to sell a generic version only of the original formulation but not the replacement,” FTC says in an ...

Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...

The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...

The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year. The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug. Boniva h...