Par
Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its
wholly-owned subsidiary, Kali Laboratories, Inc., has received final
approval from the U.S. Food and Drug Administration for its Abbreviated New
Drug Application for tranylcypromine sulfate tablets, 10 mg.
Tranylcypromine is the generic version of GlaxoSmithKline's Parnate(R) and
is used for the treatment of depression. Annual U.S. sales of Parnate(R)
exceed $6 million. Par will begin shipping the product immediately.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets
generic drugs and innovative branded pharmaceuticals for specialty markets.
In 2005, Par received approval for and introduced the appetite stimulant
Megace(R) ES, its first branded pharmaceutical product. Par's Generic
Products Division is committed to providing high-quality pharmaceuticals
that are affordable and accessible to patients. Par manufactures, markets
or licenses more than 110 generic drugs. For press release and other
company information, visit parpharm.
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995. To the extent any statements made in this news release contain
information that is not historical, these statements are essentially
forward- looking and are subject to risks and uncertainties, including the
difficulty of predicting FDA filings and approvals, acceptance and demand
for new pharmaceutical products, the impact of competitive products and
pricing, new product development and launch, reliance on key strategic
alliances, uncertainty of patent litigation filed against us, availability
of raw materials, the regulatory environment, fluctuations in operating
results and other risks and uncertainties detailed from time to time in the
Company's filings with the Securities and Exchange Commission, such as the
Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.
parpharm
Комментариев нет:
Отправить комментарий