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Innovus Pharmaceuticals, Inc. (INNV)

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Awaiting Official Announcement of FDA Approval for FlutiCare

FlutiCare Approval could bring a BILLION DOLLARS in sales annually

REDONDO BEACH, CA--(Marketwired - Jul 12, 2016) -, a leading financial news and information portal offering free real time public company filing alerts, discusses the potential impact of the anticipated FDA ruling on Innovus Pharmaceuticals' (OTCQB: INNV) ANDA filing for FlutiCare™, the company's over-the-counter treatment for allergic rhinitis.

FlutiCare™ is designed to treat non-allergic rhinitis -- better known as "hay fever" or "stuffy nose" -- which affects roughly 50 million Americans each year. While 70% of these individuals use over-the-counter products, more than half are not satisfied with the treatment option, according to an Asthma and Allergy Foundation of America survey, which suggests there's an opportunity for a prescription-strength OTC treatment option to capture market share from category leaders.

As the #1 prescription nasal steroid with over 177 million units sold since 2007, Innovus believes that the over-the-counter version of FlutiCare™ could be worth up to $1 billion per year by addressing a much wider over-the-counter market. The FDA decision is expected in the next several weeks.


The CEO has already signed an agreement for the manufacturing of FlutiCare

Innovus Pharma Achieves Major Milestone With Securing a Manufacturing Agreement for FlutiCare in Anticipation of the FDA Decision

SAN DIEGO, CA--(Marketwired - May 31, 2016) - Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB: INNV), an emerging commercial stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men and women's health and respiratory diseases, today announced that it signed a manufacturing agreement for the supply of its FlutiCare™ 60 and 120 spray/bottles.  Innovus signed the agreement in anticipation of the FDA's decision, expected between July-September of this year, on the ANDA application for the drug.


Prior to joining Innovus Pharma,

Dr. Damaj served as President and Chief Executive Officer of Apricus Biosciences, Inc. 
where he helped move the company's stock price from
19 Cents to $6.00 !!!
(Uplisted from OTC to NASDAQ)


Company Profile:

Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men's and women's health and vitality. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has an additional five marketed products in this space, including (e) Sensum® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), (f) Zestra Glide®, (g)Vesele® for promoting sexual and cognitive health, (i) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.

Business Summary:

Innovus Pharmaceuticals, Inc., a pharmaceutical company, engages in the commercialization, licensing, and development of non-prescription medicine and consumer care products in the United States. Its products include Zestra, a non-medicated patented consumer care product to enhance desire, arousal, and satisfaction in women; EjectDelay, an over-the-counter monograph-compliant benzocaine-based topical gel for treating premature ejaculation; Sensum+, a non-medicated consumer care cream that enhances penile sensitivity; Zestra Glide, a high viscosity and low osmolality water-based lubricant; Vesele, a proprietary oral dietary supplement to enhance nitric oxide beneficial clinical effects on sexual functions and brain health; and Androferti to support overall male reproductive health and sperm quality. The company?s pipeline products includes FlutiCare, an over the counter drug for Rhinitis; Urocis for urinary tract infection; and AndroVit, a proprietary supplement to support overall prostate and male sexual health. The company markets and sells its products through commercial partners to primary care physicians, urologists, gynecologists, and therapists; and directly to consumers through online channels, retailers, and wholesalers. Innovus Pharmaceuticals, Inc. was incorporated in 2011 and is based in San Diego, California.

Bassam Damaj, Ph.D.
President and Chief Executive Officer:

Dr. Bassam Damaj was appointed to serve as our President and Chief Executive Officer in January 2013. Prior to joining Innovus Pharma, Dr. Damaj served as President and Chief Executive Officer of Apricus Biosciences, Inc. (NASDAQ: APRI), a specialty pharmaceutical company, from December 2009 until November 2012. At Apricus Bio, Dr. Damaj was responsible for the approval of its lead drug Vitaros, a treatment for erectile dysfunction. Dr. Damaj also signed multimillion dollar partnerships between Apricus Bio and leading pharmaceutical companies such as Abbott, Novartis-Sandoz and Takeda. Before Apricus Bio, Dr. Damaj was a co-founder of Bio-Quant, Inc. and served as the Chief Executive Officer and Chief Scientific Officer and a Director of Bio-Quant's board of directors from its inception in June 2000 until its acquisition by Apricus Biosciences in December 2009. In addition, Dr. Damaj was the founder, Chairman, President and Chief Executive Officer of R&D Healthcare, and the co-founder of Celltek Biotechnologies. He also served as a Director of the Board of Directors at CreAgri, Inc. and was a Member of the Scientific Advisory Board of MicroIslet, Inc. He is the author of the Immunological Reagents and Solutions reference book, the inventor of many patents and author of numerous peer reviewed scientific publications. Dr. Damaj won a US Congressional award for the Anthrax Multiplex Diagnostic Test in 2003. Dr. Damaj holds a Ph.D. degree in Immunology/Microbiology from Laval University and completed a postdoctoral fellowship in molecular oncology from McGill University.

Who are the major players at Innovus Pharma?


Share Structure:

Shares Outstanding:     150.5 Million (as of 4/28/17)   Dr. Damaj owns $23.7M shares.  Novalere owns 25.6M.  One person and One Entity own ~ 32.8% of the outstanding shares. 

Profitability expected exiting Q4 2017 !
- 2017 Projected Revenue of $15M (NOT counting FlutiCare), which would be approximately 3x GREATER than 2016. 


Company Videos:

Innovus Pharma CEO Provides Shareholder Update and Conference Call

Corporate Presentation November 2016 (8-K  11/1/2016)

Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)

Innovus Pharma (INNV): Targeting $3+ Billion Markets With 13 Commercial Products

Major 2016 Accomplishments:



Where can INNV products be seen?


Existing Product Lines @ Innovus Pharma:

Newest Product:


PROSTAGORX™ is a clinical strength, multi response prostate supplement, scientifically formulated to effectively maintain good prostate health and help in prevent prostate issues in the future. ProstaGorx™ was developed by top medical doctors and produced in a top-quality, cGMP certified and FDA registered laboratory environment under the most rigorously professional conditions. 

The positive benefits provided by the individual and combination ingredients in ProstaGorx™ have been published in leading medical journals.


Are you looking to boost your brain health?r

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INNV News: Current Report Filing (8-k) 01/08/2018 06:08:26 AM
INNV News: Quarterly Report (10-q) 11/14/2017 04:41:42 PM
INNV News: Current Report Filing (8-k) 11/14/2017 04:24:20 PM
INNV News: Current Report Filing (8-k) 11/14/2017 06:13:49 AM
INNV News: Statement of Changes in Beneficial Ownership (4) 10/02/2017 04:57:33 PM
#13070  Sticky Note Innovus Pharma Announces U.S. Food and Drug Administration kkpennies 01/11/18 10:21:10 AM
#12430  Sticky Note !!! $INNV Investor Starter Guide !!!! John Kent 11/20/17 10:31:19 AM
#11803  Sticky Note $19B market. I think I'd be loading up BooDog 10/03/17 06:04:18 AM
#13116   Nice, b2. You could be looking at a Batermere 01/17/18 11:18:17 PM
#13115   Finally in the black on my 500,000 shares. biotech2 01/17/18 10:22:45 PM
#13114   My bad. Highest close since July. Excellent to Clev3land 01/17/18 04:10:13 PM
#13113   Highest close since August. There is a reason Clev3land 01/17/18 04:07:05 PM
#13112   Pretty good challenge on the .12's. Take 'em out!! BooDog 01/17/18 01:47:45 PM
#13111   My Buddies just took a Beating with HTGM, freparkng 01/16/18 06:26:41 PM
#13110   Loving the news here John Kent 01/16/18 12:28:01 PM
#13109   Snup, Indeed! Should be a solid 2018. I would jbdiver 01/16/18 11:12:00 AM
#13108   Jb, quite a horse race with both our stocks snupoled 01/16/18 10:03:00 AM
#13107   should be a green monday! jbdiver 01/16/18 08:42:46 AM
#13106   Another Canada Approval / News GL freparkng 01/16/18 08:18:26 AM
#13105   I'm impressed with INNV's rock-solid stability today! Booh-Yah!!! gi197845 01/15/18 08:59:45 AM
#13104   And the Browns will win the Super Bowl twistedfreak 01/14/18 03:50:51 PM
#13103   Aveo at these prices would be like handing Clev3land 01/14/18 02:34:51 PM
#13101   Oh, my bad. I'm not concerned with AVEO's twistedfreak 01/14/18 08:36:54 AM
#13100   I was talking about AVEO. jtaylor68 01/14/18 06:54:09 AM
#13098   Jan 17, 2017: .20 (at this point, it twistedfreak 01/13/18 10:02:09 AM
#13096   I agree, this is going to be INNV's jtaylor68 01/12/18 08:55:31 AM
#13095   Probably as accurate as your 0.07 prediction. jtaylor68 01/12/18 08:43:40 AM
#13094   Down 35% from 52 week high. 50-70% lower jtaylor68 01/12/18 08:41:44 AM
#13093   Wait til FDA approves the diabetes strips. You Clev3land 01/12/18 08:14:35 AM
#13092   LOL. $6 x current or A/S= $1B to twistedfreak 01/12/18 06:34:59 AM
#13090   Or a more likely scenario: once Mgt gobbles twistedfreak 01/12/18 05:36:14 AM
#13089   2018 is going to be the breakout year Clev3land 01/12/18 05:13:52 AM
#13088   In my opinion the train left 3 days Clev3land 01/12/18 05:10:04 AM
#13087   Ok Boys and Girls, we got a freparkng 01/11/18 11:03:16 PM
#13086   I was kidding about the $4 Buyout, twisted. Batermere 01/11/18 10:28:04 PM
#13085   LOL. AVEO is holding a 300% gain after twistedfreak 01/11/18 09:24:29 PM
#13084   Between Islamorada and Marathon in FL Keys. Closer twistedfreak 01/11/18 09:21:40 PM
#13083   Pump and dump? I think you're talking about aveo Mwilson1 01/11/18 08:49:04 PM
#13082   Appears company semi stable, will put in freparkng 01/11/18 06:36:18 PM
#13081   Whereabouts is Duck Key, twisted? Sounds like you Batermere 01/11/18 06:21:32 PM
#13080   Clev3land: Just leaning back at home after 30 twistedfreak 01/11/18 05:46:00 PM
#13079   Can anyone tell me what, CYTR, INNV, GALE, gi197845 01/11/18 04:29:15 PM
#13078   Just may break the down trend for good BooDog 01/11/18 04:04:09 PM
#13077   jb, sure is, both are moving nicely, snupoled 01/11/18 03:33:39 PM
#13076   I wouldn't hold my breath on the original ShawnP123 01/11/18 02:24:27 PM
#13075   @stockgenius45, I'm not short on INNV, just frustrated gi197845 01/11/18 01:03:21 PM
#13074   gi97845 is getting desperate today... Posts today are stockgenius45 01/11/18 12:53:53 PM
#13073   Without international sales of Fluticare, INNV could end gi197845 01/11/18 12:33:01 PM
#13072   Well, will the original Fluticare ANDA ever get gi197845 01/11/18 12:19:51 PM
#13071   Excellent. Launching this quarter and 2nd half 2018 BooDog 01/11/18 11:30:19 AM
#13070   Innovus Pharma Announces U.S. Food and Drug Administration kkpennies 01/11/18 10:21:10 AM
#13069   FDA Clearance. Caveat Emptor 01/11/18 09:13:53 AM
#13068   Boom this was a no brainer from day one John Kent 01/11/18 07:49:29 AM
#13067   Where is T.F. predictions coming to fruition?... Clev3land 01/10/18 06:48:00 PM
#13066   Im looking for some double barrel action these jbdiver 01/10/18 06:04:08 PM
#13065   JB, so fare elite is winning, snupoled 01/10/18 04:51:31 PM
#13064   jesus... can she hold .10 today smh jbdiver 01/10/18 01:29:33 PM
#13063   Infamous Pharmaceuticals is really kicking-butt! Go Dr.Damaj, go! gi197845 01/10/18 01:03:15 PM