Generics

PHILADELPHIA — The statewide trade organization for life sciences company in Pennsylvania, which has been named Pennsylvania Bio, announced Wednesday that it would be changing its name and brand. 

 

HYDERABAD, INDIA and PRINCETON, N.J. — Dr. Reddy’s Laboratories and Gland Pharma have announced a strategic collaboration to market and distribute eight injectable generics. 

 

The portfolio includes hospital- and clinic-administered products for which abbreviated new drug applications (ANDAs) have been filed, and some whose ANDAs will be filed imminently, the companies said. The combined U.S. sales of the drugs for 12 months ending August 2016 were about $1 billion, according to IMS Health moving annual total data. 

DAYTON, N.J. — The Food and Drug Administration has approved Aurobindo Pharma’s generic of Lunesta (ezopiclone), the company announced Wednesday. The drug is indicated to treat insomnia. 

 

Aurobindo’s generic will be available in 1-, 2- and 3-mg dosage strengths. The drug had an estimated market size of $78.8 million for the 12 months ended August 2016. 

 

In the aftermath of the Food and Drug Administration’s proposal to withdraw its approval of Lannett’s methylphenidate hydrochloride extended-release tablet — which led to its stock falling 12.9% last week — the company has responded to the regulatory notice. 

 

BAUDETTE, Minn. — ANI Pharmaceuticals has launched its benztropine mesylate tablets, the company announced Tuesday. The drug is the tenth commercial introduction the company has seen in 2016, according to CEO Arthur Przybyl. 

 

ANI’s benztropine mesylate tablets will be available in 0.5-, 1-, and 2-mg dosage strengths. The product has a current market size of about $25 million, according to IMS Health data. 

 

WASHINGTON — On Oct. 21, the Food and Drug Administration held a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) II. At the meeting were various stakeholders, including the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, who outlined the goals of GPhA and the FDA in negotiations over the second iteration of GDUFA. 

 

WASHINGTON —  Vanda Pharmaceuticals announced Tuesday that it had entered a license agreement with Taro to resolve its litigation against Taro’s for its abbreviated new drug application seeking approval for a generic of Vanda’s Fanapt (iloperidone).