Theratechnologies returns HIV product Egrifta to U.S.

Canada's Theratechnologies says it is again shipping its 1-mg dose of its Egrifta to U.S. wholesalers. Manufacturing problems had led it to halt production earlier this year of the human growth hormone which is used by some HIV patients.

The first batch of the 1-mg dose has gone out and new batches will be available over the next weeks, the company said Wednesday. The Montreal, Quebec-based company stopped making a 2-mg dose in February when it ran into production issues.

Egrifta is a synthetic form of growth-hormone-releasing hormone (GHRH) which is used in the treatment of HIV-associated lipodystrophy. In May, citing the shortage and the "critical need" for patients, the company said that it intended to ship some "additional limited supplies" of the 2-mg form but then retracted that promise three days later. After further consultations with regulators, the company returned to making the 1-mg dose in June.

The FDA has been working closely with drugmakers on creative solutions when there have been shortages of critical medications. It allowed Johnson & Johnson's ($JNJ) Janssen unit to take over a portion of a closed Boehringer Ingelheim plant for 6 months this year to ensure production of its popular ovarian cancer drug Doxil. The special arrangement allowed Janssen to produce enough supply to last at least 9 months. It has also allowed the import of saline solution from some overseas operations not approved for U.S. distribution to alleviate a shortage of that essential product.

The production problems at the Theratechnologies facility put a damper on big plans by the company after it re-acquired the U.S. marketing rights to the drug in May from marketing partner EMD Serono, a subsidiary of Merck KGaA. With new supplies arriving, the company was able to look forward again. "By assuming marketing and sales responsibilities, Theratechnologies is now poised to make significant headway in the United States," CEO Luc Tanguay said in a statement Wednesday.

- here's the announcement