Generics

MUMBAI and BALTIMORE — The Food and Drug Administration has approved Lupin’s generic of Namenda XR (memantine hydrochloride) extended-release capsules, the company announced Thursday. The drug is indicated to treat moderate to severe Alzheimer’s-related dementia. 

 

Lupin’s generic will be available in 7-, 14-, 21- and 28-mg dosage strengths. The drug had U.S. sales of $1.22 billion for the 12 months ended June 2016, according to IMS Health data. 

 

JERUSALEM — Teva Pharmaceutical on Wednesday announced the launch of its generic of Epzicom (abacavir and lamivudine). The drug is indicated to treat HIV-1 in combination with other retroviral agents. 

 

Teva’s generic will be available in 600-mg abacavir/300-mg lamivudine dosage strength. The drug had U.S. sales of about $449 million for the 12 months ending July 2016, according to IMS Health. 

 

MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Tuesday announced an exclusive agreement with Pharmathen to develop and distribute a generic product in a market category that had more than $500 million in sales for the 12 months ended July 2016, according to IMS Health data. 

 

Under the agreement, Pharmathen will develop, manufacture and supply the product, 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. 

WESTON, Fla. — Apotex has re-entered the market with its generic Floxin Otic (ofloxacin otic solution, 0.3%), whose availability the company announced Tuesday. 

 

The drug will be available in 5- and 10-mL bottles. 

 

BRIDGEWATER, N.J. — Ajanta Pharma on Monday launched its generic of Zegerid (omeprazole and sodium bicarbonate) powder for oral suspension. The drug is indicated to treat gastroesophageal reflux disease (GERD), ulcers and inflammation of the esophagus. 

 

Ajanta’s generic with be available in 20- and 40-mg omeprazole/1680-mg sodium bicarbonate dosage strengths. 

 

SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto), a biosimilar of AbbVie’s Amgen (adalimumab) and the fourth U.S. biosimilar, the company announced Friday. The drug — Amgen’s first biosimilar — is indicated to treat seven inflammatory conditions, among them moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe chronic plaque psoriasis. 

 

DUBLIN — Endo has a new president and CEO. 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.