IPXL - Sector: Healthcare---Industry: Biotechnology & Drugs

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4)
2006 details & milestones

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5)
Financial update:
The negative cash flow (due to capital expenditures) is a concern &
IPXL still have the following issue to be solved asap IMO:

IMPAX has been unable to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2004, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. IMPAX's failure to file these periodic reports violated Nasdaq Marketplace Rule 4310(c)(14), compliance with which is required for continued listing on Nasdaq.

If this issue will be solved, IPXL should be traded much higher as now!
more details (29 slides):
http://library.corporate-ir.net/library/67/672/67240/items/219410/IPXLNov062.pdf

Feedback & comments are appreciated
cheers
Oliver

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update:
1)
Investment Conclusion
While we view the appointment of new auditor as
an important milestone in Impax's journey, it by no
means guarantee near-term resolution of the
revenue recognition issue. We remain optimistic
that Impax could be in a position to report its
financials in early 2007.

Summary

This morning, Impax announced the appointment
of Grant Thornton (GT) as its new auditor, who will
take over for Deloitte & Touche (D&T) after
completion of the 2004 audit. Recall, in Nov '05,
Impax announced D&T had decided not to
continue the relationship post 2004 audit.

This is encouraging as we believe GT's
willingness to take Impax on as a client now, prior
to a decision re. revenue recognition, suggests the
auditor believes the revenue recognition issue is
ultimately solvable. Additionally, timing of the
appointment will allow GT to be physically at
Impax facilities to test internal controls for CY06,
an important step under Sarbanes Oxley that must
be completed during the same CY. While GT will
not be involved in the revenue recognition
decision, its understanding of the issues and
knowledge of Impax's business should help to
facilitate the eventual transition from D&T.

2)
MPAX Receives Final FDA Approval and First-to-File Status for Generic Version of Ditropan(R) XL 15 mg
Friday November 10, 10:41 am ET
- Marketing to Begin Immediately -

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan® XL, Extended-release Tablets, 15 mg (Oxybutynin Chloride Extended-release Tablets 15 mg). The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL 15 mg were approximately $58 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

The Company's version of generic Ditropan XL 15 mg is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA - News). Teva plans to begin marketing the product immediately.

"We are very pleased to now have eight FDA approvals this year and look forward to working with our partner on the launch of our generic version of 15 mg Ditropan XL," said Larry Hsu, President and Chief Executive Officer of IMPAX Laboratories. "We had expected this approval following the September 2006 appeals court ruling in our favor in a patent infringement suit brought against us by Alza," he added.

The Company noted that it continues to have tentative approval for its 5 mg and 10 mg versions of generic Ditropan XL. Conversion of the 5 mg and 10 mg strengths from tentative approval to final approval is contingent upon the expiration of any generic marketing exclusivity by other applicants. Final approval also is dependent upon FDA's evaluation of any new information subsequent to the tentative approval. Wolters Kluwer Health estimates that U.S. sales of all dosage forms of Ditropan XL Extended-release Tablets were approximately $338 million in the 12 months ended August 31, 2006.

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Update on IPXL (clcl2002us quotation)!_

3 major events

1) gWXL approvals (any time).

2) gConcerta approval (any time).

3) Financial Filing (1Q07).

Other significant events:

1) Vadova Full Response (4Q06).

2) Vadova (2007).

3) gOxycodone (settle with Purdue? possible. Otherwise (ENDO withdraw
at 2006 End and TEVA may withdraw in future), if Impax wins the
litigation, this product will become a money cow.

4) gEffexor XR (2008).

5) gAdderall XR (2009).

6) gAllegra-D (2007?).

2005 EPS $0.30.
2006 EPS $0.40 (assuming w/o gWXL, gConcerta).
2007 EPS >$1.00

cheers
O.

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SAC Capital Advisors, SAC Capital Management has bought 5% of IPXL shares 

http://phx.corporate-ir.net/phoenix.zhtml?c=67240&p=irol-SECText&TEXT=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvZmlsaW5nLnhtbD9yZXBvPXRlbmsmaXBhZ2U9NDUxMTY3MyZhdHRhY2g9T04=

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positive FDA news:
IMPAX Announces FDA Approval of Generic Wellbutrin XL 300 mg
Monday December 18, 8:00 am ET
Product Launched Under Exclusivity Transfer Agreement with Anchen and Teva

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC: IPXL - News; "IMPAX" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin XL, 300 mg. The product has been launched, pursuant to an Exclusivity Transfer Agreement with Anchen Pharmaceuticals, Inc. and a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA - News).

Anchen obtained approval of its generic Wellbutrin XL product, and in accordance with this agreement, selectively waived its 180-day period of marketing exclusivity in favor of IMPAX Laboratories. Pursuant to the Company's existing strategic alliance agreement with Teva, Teva has U.S. marketing rights to IMPAX's version of this product. Wellbutrin XL 300 mg, marketed by GlaxoSmithKline, had U.S. sales in excess of $1.0 billion for the 12 months ended October 31, 2006, according to Wolters Kluwer Health.

Under the Exclusivity Transfer Agreement, Teva will make certain payments to Anchen in return for a waiver of its exclusivity to IMPAX. In addition, Teva is indemnifying IMPAX against certain losses that might arise from certain legal risks.

"We are very pleased to have received our ninth FDA approval this year, and look forward to offering patients this widely sold anti-depressant as a generic drug beginning immediately," commented Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX Laboratories.

"In addition, generic Wellbutrin XL is the first of our Tier 3 products to be marketed under the 12-product Strategic Alliance Agreement signed with Teva in July 2001. Under that agreement, upon the first launch date of any Tier 2 or Tier 3 product in the U.S., IMPAX plans to repurchase for $1.00, 16.67% of the IMPAX common stock, or approximately 244,000 shares, sold to Teva during the development phase of the agreement," Dr. Hsu added.

Both the IMPAX and Anchen ANDAs for generic Wellbutrin 300 mg were filed with Paragraph IV certifications with respect to certain patents held by Biovail Laboratories International SRL and listed in the Orange Book. Biovail initiated patent infringement lawsuits against both companies. The IMPAX litigation is ongoing, and IMPAX has filed a motion for summary judgment of noninfringement. Anchen has been granted summary judgment of noninfringement with regard to the Anchen product.

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nice news, nice chart   

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now it´s getting interesting 

1)
Lehman Brothers' Analysis for gWXL   (Not rated)       21-Dec-06 10:47 am   
For anyone who isn't a conspiricy theorist concerning stock analysts, here is LB's analysis for gWXL:


GENERIC WELLBUTRIN XL 300MG PROVIDES SIGNIFICANT OPPORTUNITY FOR IMPAX: Wellbutrin XL 300mg represents a significant market opportunity with meaningful financial contribution expected for Impax for the next several quarters. For Impax, we estimate untaxed EPS contribution of about $0.55 during the 6-month exclusivity (or fully-taxed EPS of approximately $0.35 for the same period). Our forecast makes the following assumptions: (1) $1B brand sales for the 300mg strength and 2-player market for 6 months; (2) generic discount of 45-55% assuming an authorized generic, identity unknown yet; (3) Teva averaging 35-45% market share during the exclusivity period; and (4) pre-split gross margin of 70-80% and Impax's split is 40%. Note that we normally assume that Impax receives 60% of gross profit under the Teva alliance, which has been reduced in this case to account for pay out to Anchen for the FTF status.

Post exclusivity, the profitability from Wellbutrin XL would diminish depending on the number of additional competitors. Other known filers of generic Wellbutrin XL include Abrika (being acquired by Actavis) and Watson Pharmaceuticals. Assuming a 4-player market for a 12-month period post exclusivity, we estimate potential untaxed EPS contribution of about $0.20-$0.30 (or $0.15-$0.20 fully taxed) for Impax, which assumes the 150mg strength is on the market around mid-07. We assume that Anchen does not launch its own generic for the foreseeable future and will continue to receive payout from Impax/Teva.
link:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=23216&tid=8644&mid=8644&tof=4&frt=2

2)
Biovail Sues FDA Over Wellbutrin XL 300mg Generic >BVF

Dec 21, 2006 17:26:00 (ET)

TORONTO (Dow Jones)--Biovail Corp. (BVF) has launched a lawsuit against the U.S. Food and Drug Administration contesting the regulator's approval of a high-dose generic of its key Wellbutrin XL drug.

As reported Dec. 15, privately held Anchen Pharmaceuticals received approval for generic versions of 150mg and 300mg doses of Wellbutrin XL, Biovail's biggest-selling drug. A few days later, Anchen, along with Teva Pharmaceutical Industries Ltd. (TEVA) and Impax Laboratories Inc. (IPXL), announced a three-way agreement allowing for the immediate launch of the 300mg version of the drug.

According to court documents, Biovail, Canada's largest publicly traded pharmaceutical company, says the FDA's approval of Impax Laboratories Inc.'s (IPXL) 300mg generic of Wellbutrin XL "violates the mandatory, statutory 30-month stay to which Biovail is entitled."

It's asking the court to force the FDA to suspend approval of Impax's generic until the expiration of the 30-month stay, or the resolution of the patent suit, whichever comes first.

U.S. law says that, if a patent owner files an action for infringement against an generic applicant within 45 days, approval of the generic is stayed for 30 months. The 30-month stay protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to a potentially infringing product.

But the FDA, in a response filed Wednesday, said it's just following the rules.

"Although Biovail filed a timely patent lawsuit on the 150mg strength, Biovail did not file its patent lawsuit on the 300mg strength Wellbutrin XL within the 45 days required by the (Food and Drug Cosmetic Act), and therefore, is not entitled to a 30-month stay on approval of Impax's generic of that strength," the FDA said in a court filing. "Moreover, Biovail recognized its failure when it amended - 30 days too late - its first patent suit to include the 300mg strength."

The FDA noted that Biovail has benefitted from a monopoly on the antidepressant, and it seeks to "perpetuate" that monopoly through this lawsuit while decreasing the availability of low-cost, reliable and safe drugs for the public.

Officials from Biovail weren't available to comment.

In an interview, Arthur Koch, chief financial officer at Impax, said Biovail's tardiness in filing a patent suit on the 300mg strength was beneficial to Impax, as it would have been subject to the 30-month stay otherwise. He said the 300mg generic has already hit the market.
The 300mg dose of Wellbutrin XL accounted for about $972 million in U.S. sales for the 12 months ended Sept. 30.
"There are many reasons that one would do an arrangement like this," Koch explained. "Teva has very substantial marketing capabillities, we do have substantial marketing and manufacturing capabilities, and Anchen had the contribution it made. The parties each brought something of value to the group, and an arrangement was made."
He also noted that its application for the 150mg version remains active, and it looks forward to the opportunity to launch that as soon as it's able.
Biovail and the FDA have butted heads over this drug before. In August, Biovail launched a lawsuit against the FDA to enforce criteria set forth in its Citizens Petition, which demanded certain criteria be employed by the regulator in determining bioequivalence of Wellbutrin XL generics.
In approving Anchen's generic last week, the FDA dismissed Biovail's petition outright, saying it determined its standards for approval were "appropriate."

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IMPAX Reports SEC Actions
Tuesday January 2, 5:25 pm ET

HAYWARD, Calif.--(BUSINESS WIRE)--IMPAX Laboratories, Inc. (OTC:IPXL - News; "IMPAX" or the "Company") reported that on Friday December 29, 2006, the Securities and Exchange Commission ("SEC") issued an order instituting an administrative proceeding to determine whether, in light of the Company's failure to file reports since September 2004, the registration of its securities under Section 12 of the Securities Exchange Act of 1934 should be suspended or revoked. An Administrative Law Judge will consider the evidence in this matter and is ordered to issue an initial decision within 120 days. Also on December 29, 2006, the SEC suspended trading in IMPAX shares during the 10-business-day period from December 29, 2006 through January 16, 2007 because of the Company's failure to file reports.

The Company has not filed a periodic report since its report for the period ended September 30, 2004 because, as it announced in May 2005, it has been working to determine the appropriate accounting treatment for transactions under its Strategic Alliance Agreement with an affiliate of Teva Pharmaceutical Industries, Ltd. The Company continues to make significant progress in determining the appropriate accounting treatment and completing its 2004 and 2005 financial statements and is optimistic that its continued progress will enable it to avoid such suspension or revocation of the registration of its securities.

The Company understands that trading in its stock may resume on January 17, 2007 and that dealers will be permitted to publish quotations only on behalf of customers that represent customers' indications of interest and do not involve dealers' solicitation of such interest.

The Company also reported that its available cash and investments at December 31, 2006 was approximately $30.2 million. The Company continues to actively develop, manufacture and ship products and received nine FDA approvals during 2006, including the recent approval of its generic version of Wellbutrin XL 300mg, a product marketed by GlaxoSmithKline that had U.S. sales of $1.0 billion during the 12 months ended October 31, 2006 according to Wolters Kluwer Health.

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ANSWER OF RESPONDENT
IMPAX LABORATORIES, INC.


Respondent Impax Laboratories, Inc. ("Impax" or the "Company") submits this Answer to the allegations relating to the Company contained in the Order dated December 29, 2006.

1. Impax denies that it is located in Bedford Park, Illinois, that it has since 2001 filed reports on forms used by small business issuers, and, upon information and belief, that it has ever had an officer or director who at one time served as an officer or director of respondent Phoenix Waste Services Company, Inc. or has had any affiliation or association of any kind with any of the other respondents herein. Impax admits that it is delinquent in its periodic filings with the Commission, having not filed a periodic financial report since it filed its report on Form 10-Q for the period ended September 30, 2004, and alleges that it has filed 35 current reports on Form 8-K since filing its last Form 10-Q. Impax denies that it is necessary or appropriate for the protection of investors to suspend or revoke the registration of any class of its securities registered pursuant to Section 12 of the Exchange Act and in support thereof alleges as follows.

2. Impax develops, manufactures and distributes generic and selected branded pharmaceutical products. It continues to conduct active operations in all respects. It currently markets 68 generic products, has applications for approximately 20 products pending before the FDA, and has 55 products under development. During 2006 alone it received FDA approvals of nine products, including a recent approval of its generic version of Wellbutrin XL 300mg, a product marketed by GlaxoSmithKline that, according to published industry data, had U.S. sales of $1.0 billion during the 12 months ended October 31, 2006. At December 31, 2006, Impax had available cash and investments of approximately $30.2 million. On December 28, 2006, the day prior to the Commission's suspension of trading in Impax's stock, the stock traded at $9.80 per share and the Company's market capitalization was approximately $600 million.

3. Impax has, upon information and belief, several thousand stockholders, including institutional and other sophisticated investors. Throughout the period since its last Form 10-Q report the Company has continuously apprised investors of developments concerning new product launches and developments in the patent-infringement litigation that necessarily accompanies its business. It has kept reasonably current an investor presentation on its Web site, a copy of which is attached as an Appendix hereto, disclosing the developments in and status of the Company's business, including cash and debt balances and capital expenditures. Throughout the period, industry publications, widely read by investors and analysts who follow the pharmaceutical industry, have published monthly data concerning sales of Impax's products.

4. Impax's failure to file financial reports since its third quarter of 2004 Form 10-Q stems exclusively from a 2001 Strategic Alliance Agreement with a subsidiary of Teva Pharmaceutical Industries, Ltd., a large generic pharmaceutical company. The agreement provided for Impax's development and manufacture of 12 new generic products to be marketed by Teva under exclusive license from Impax, with profits to be shared by the two companies. The agreement also provided (i) for Teva to lend $22 million to Impax and purchase $15 million of its common stock, (ii) for repayment of the loan with shares of Impax common stock at Impax's option, (iii) for loan interest and principal forgiveness to the extent Impax met specified product-development milestones or in exchange for retention of market exclusivity, (iv) for Impax to repurchase a portion of its shares for nominal consideration when a specified milestone had been achieved, and (v) for the parties to share specified regulatory and patent-litigation expenses. Launch of the first product with potential for generating significant revenue under the agreement occurred in February 2004.

5. Under the agreement, Teva is required to reimburse Impax for its cost of manufacturing the products within 30 days following Impax's sale of the products to Teva, to provide Impax with monthly reports of Teva's sales of the products to its customers, and to pay Impax its share of the profits from those sales on a quarterly basis. Impax elected to recognize both the cost-reimbursement and profit components of this revenue at the time title and risk of loss of the products passed from Teva to Teva's customers. It followed this revenue-recognition policy through the third quarter of 2004.

6. During the third quarter of 2004, Impax received sales reports from Teva revealing that Teva had mistakenly omitted certain price adjustments from its product sales reports for the first two quarters of 2004, resulting in its overstatement of Impax's profit share for those two quarters. Impax relied upon Teva's sales reports in preparing its own financial statements and, as a result of these reporting errors, restated its first- and second-quarter results, reducing its previously reported first-quarter revenues from $38.8 million to $34.5 million and net income from $9 million to $5.2 million and reducing second-quarter revenues from $30.8 million to $30.6 million and net income from $0.6 million to $0.3 million.

7. During the course of preparing the Company's 2004 annual report, Impax and its independent auditors, Deloitte & Touche LLP, re-examined the Company's method of recognizing revenue under the Teva agreement and determined that the accounting for Impax's transactions under the agreement is not clearly addressed in the accounting standards and interpretations that comprise GAAP. The Company, on Deloitte's recommendation, decided to seek the advice of the Commission's Office of the Chief Accountant (OCA). To assist it in analyzing the accounting issues presented by the agreement and preparing its submission to OCA, Impax retained the services of a national accounting consulting firm, led by a former Associate Chief Accountant of the Commission, and its regular outside corporate/securities legal team, led by a former member of the Commission's Office of the General Counsel experienced in financial reporting and disclosure.

8. Following extensive consultation with Deloitte, Impax, with the assistance of its accounting and legal advisors, made two submissions to the OCA, the first on May 26, 2005 and, following a June 10 conference call with the OCA staff, a second on November 7, 2005. While both of these submissions proposed new methods of recognizing revenue under the Teva agreement, neither included a statement of the auditors' views concerning such methods. During a January 3, 2006 conference call with the OCA, the staff declined to express its views concerning the Company's proposal until the Company's auditors' views were made known. Since that time Impax, in consultation with Deloitte, has been developing a revised submission to OCA. It has also added to its advisory team a former OCA Chief Counsel.

9. The process of developing a revised submission has included: an in-person meeting with Deloitte on January 10, 2006; delivery of four accounting "white paper" analyses to Deloitte on February 7; in-person meetings on February 27 and March 10 and telephone conferences on May 23 and June 7 with Deloitte to review its comments on the original and several revised versions of the white papers; and, between July 17, 2006 and January 3, 2007, submission to Deloitte of six successive drafts of the revised OCA submission in response to Deloitte's successive written comments and oral comments provided in telephone conferences on August 9 and 11, October 9 and December 7.

10. The length of the process of arriving at a new revenue-recognition method with which its auditors can concur has not been the result of any disagreement between the Company and its auditors. Because of the multiple deliverables under the Teva agreement ( i.e. , research and development, manufacture and delivery of 12 products, and market exclusivity) and various features potentially requiring accounting as derivative financial instruments, the analyses required to determine the appropriate method of recognizing revenue under the agreement have been unusually complex. The current draft of the OCA submission consists of a 31-page single-spaced letter and four separate appendices. The submission addresses some 18 separate provisions of the accounting literature. 1 To date, Impax has incurred approximately $3.1 million of audit and consulting expenses in connection with its 2004 audit.

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WR Hambrecht: Teva underpriced
"If Teva is smart, it will announce the purchase of Impax Labs, Merck KGA by mid-February."

Roee Bergman 7 Jan 07   15:40
WR Hambrecht analyst Andrew Forman recommends Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) as one stock to hold ahead of the JP Morgan Healthcare Conference next week. Forman gives Teva a "Buy" recommendation.

WR Hambrecht says. "This is a global growth story, an overlooked undervalued emerging markets stock, with more accretive US generic acquisitions with Impax Labs Inc. (IPXL.PK) topping the short list with an estimated earnings per share of $0.15 in 2007, or Merck KGA generic business, which could add $0.25 or maybe both complementary to Ivax and easier to integrate, in our view. If Teva is smart, it will announce both of these deals by mid-February and can suspend 2007 guidance until 2008, or at least buy some time."

WR Hambrecht believes that Teva is "trading at historic low multiples... and with all of Wall Street already frightened about a low growth scenario for 2007, explain how a 2006 50%+ earnings growth resulted in Teva losing 28% of its value. At this juncture, it is difficult to image what Teva could say to make the stock go lower, and there seems to be no shortage of incremental buyers for Teva."

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 Citi's Notes on Jan 16   (Not rated)       16-Jan-07 07:16 pm   
➤ Impax shares have not traded since December 28th due to an SEC mandated
trading suspension; trading will begin again tomorrow on an unsolicted basis.
➤ Risk remains: an administrative hearing will proceed within 100 days to
determine whether Impax's registration should be suspended or revoked.
➤ However, in its January 8th response to the SEC, Impax suggested it could file
its revised submission to the OCA within 10 days; we view this submission as
an important first step on the road to becoming current with its financials.
➤ Operationally, Impax has made significant strides of late, launching generic
formulations of both Ditropan XL and the 300mg dose of Wellbutrin XL.
➤ Impax has also continued its development of Vadova; a submission to the
FDA in the near-term suggests a launch before year-end remains possible.
➤ We are more than doubling our 2007 earnings estimate to account for recent
launches, and we are increasing our target price to $11 (from $7) per share; reiterate Hold.

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Impax Labs: Suspension Of Registration Not Necessary
Dow Jones Newswires - January 09, 2007 6:31 PM ET

Impax Laboratories Inc. (IPXL) said Tuesday that it's not necessary for the Securities and Exchange Commission to suspend registration of the company's securities.

The SEC last month instituted an administrative proceeding to decide whether the registration of Impax's securities should be suspended or revoked. Impax filed its response with the SEC on Tuesday, saying a suspension "for the protection of investors" isn't needed.

Impax hasn't filed a quarterly or annual report since 2004. The SEC has already suspended trading in Impax shares during the period from Dec. 29, 2006, through Jan. 16, 2007, because Impax hasn't filed reports.

The Hayward, Calif., company makes and distributes generic and branded pharmaceutical products.

[SMONYSE]

Citi is now at 11 and the other analyst is at 15.  This was a widely followed stock before so I expect more analysts to follow this in the coming months.  Like the fact taht hartford went fro 9% to 14% ownership.

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US FDA approves generic version of King heart drug
Mon Apr 2, 2007 3:48 PM ET

(Recasts with generic maker, updates shares, adds background)

WASHINGTON, April 2 (Reuters) - Impax Laboratories Inc. <IPXL.PK> has won U.S. approval to market the first generic version of King Pharmaceuticals Inc.'s <KG.N> drug Corzide to treat hypertension, the U.S. Food and Drug Administration said on Monday.

After the news, shares of King Pharmaceuticals fell more than 1 percent before trading down 8 cents, or 0.4 percent, at $19.59 on the New York Stock Exchange shortly before the market  close. Corzide, also known as nadolol/bendroflumethiazide, is a type of beta blocker to treat hypertension -- unusually high blood pressure that can damage the heart. The condition can also raise the risk of heart attack, stroke and other complications. King Pharmaceuticals bought rights to the drug from Bristol-Myers Squibb Co. in 2001. It was first approved by the agency in 1983.

In its 2005 annual report, King said it was anticipating a decline in Corzide prescriptions in the face of expected competition. Representatives for the drugmaker could not be immediately reached for comment.

On Monday, the FDA granted Impax approval to market two different doses of the drug, a 40 milligram version and an 80 milligram one, according to agency spokeswoman Kimberly Rawlings.

Impax Chief Financial Officer Arthur Koch had no immediate comment on the approval but said the company would issue a news release soon.